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  • Director - Clinical Research Scientist - Global and US Medical Affairs

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Indianapolis, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary The Clinical Research Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans. Key Responsibilities 1. Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups. Lead data analyses and health outcomes research to address customer questions. Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners. Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements. Support training of sales, medical, and patient support teams. Lead definition of Patient Journey and contribute clinical perspective to patient programs. Participate in relevant professional and industry associations. 2. Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication. Address unsolicited scientific inquiries in alignment with medical governance standards. Support scientific meetings, advisory boards, symposia, and other expert engagements. Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts. Build and maintain relationships with key opinion leaders and scientific societies. Represent the company at medical congresses and support scientific booth activities. Contribute to data analyses, publication development, and Clinical Trial Registry reporting. 3. Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams. Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements. Maintain up‑to‑date understanding of clinical and competitive data. Provide regional clinical insights to inform development plans and study protocols. 4. Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication. Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out. Support investigator/site training and address study‑related medical questions. Oversee local safety monitoring and adverse event follow‑up. Review investigator‑initiated trial (IIT) proposals as needed. Ensure global alignment of Phase 3b/4 and applicable early‑phase studies. 5. Regulatory Support Contribute to development and review of local labeling and labeling changes. Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities. Participate in risk management planning with global and local teams. 6. Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape. Provide scientific training to clinical study teams and act as a protocol subject‑matter expert. Represent the organization at medical congresses and contribute to medical budget planning. Seek opportunities for external scientific engagement. 7. Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports. Contribute to recruitment, diversity, and retention efforts when applicable. Participate in committees, Six Sigma initiatives, and cross‑functional projects. Model leadership behaviors and serve as an ambassador for patients and the company. Basic Qualifications An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience Additional Preferences Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information) Ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $177k-308k yearly Auto-Apply 13d ago
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  • Clinical Research Associate (Start Up) - Cross Therapeutic - Columbus, OH

    Ire

    Clinical research associate job in Indianapolis, IN

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Columbus, OH area; near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $52k-83k yearly est. Auto-Apply 4d ago
  • Clinical Research Associate (CRA)

    Pharmavise Corporation

    Clinical research associate job in Indianapolis, IN

    Job Description . We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities. Key Responsibilities: Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring. Act as the primary liaison between internal study teams and external third-party organizations (TPOs). Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data. Manage and track clinical queries to ensure timely resolution. Collaborate with internal teams to align clinical research processes and operational strategies. Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements. Minimum Qualifications: Bachelor's degree in a relevant field. 6+ years of experience in clinical research or a related industry. Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant. 3+ years of experience in project management or a related role. Prior experience in pharmaceutical, diagnostics, or CRO environments. Strong organizational skills with attention to detail. Ability to effectively communicate with diverse stakeholders. Proficiency in Microsoft Excel for data tracking and reporting. Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms. Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases. Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
    $52k-83k yearly est. 11d ago
  • Clinical Research Associate (Start Up) - Cross Therapeutic - Columbus, OH

    Icon Central Laboratories

    Clinical research associate job in Indianapolis, IN

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Columbus, OH area; near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $52k-83k yearly est. Auto-Apply 5d ago
  • Principle Research Scientist - Clinical Operations

    Elanco 4.9company rating

    Clinical research associate job in Indianapolis, IN

    At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Clinical Development Scientist, Parasiticides Conduct and coordinate global clinical development programs, including effectiveness and Target Animal Safety (TAS), from inception through approval in initial target geographies. Reporting to the Clinical Leader, this role designs and executes studies that advance Elanco's innovation pipeline to customers. Your Responsibilities Plan, coordinate, implement, and report high-quality clinical effectiveness and TAS programs to support development of new parasiticide products for pets and farm animals, including pilot and pivotal studies conducted in compliance with global regulatory standards and guidelines such as GLP, vGCP, and VICH. Formulate comprehensive clinical development plans for new products and build effective cross-functional relationships across Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing, and Quality to ensure timelines and quality expectations (GCP, GLP) are met throughout development and lifecycle management. Execute individual clinical programs in collaboration with CDS, Biostatistics, and Regulatory Affairs, including designing and authoring protocols for laboratory and field efficacy studies and TAS studies to support regulatory approvals. Work with CDS to select appropriate internal research sites or external Contract Research Organizations (CROs) and qualified investigators to execute study protocols. Coordinate study monitoring activities to ensure compliance with applicable regulations, company policies, and management expectations. Analyze and interpret study results with support from Data Management, Medical Writing, Biostatistics, and internal or external subject matter experts, and author high-quality study reports. Partner with Regulatory Affairs to prepare clinical reports and datasets for submission to regulatory agencies and present data to regulatory authorities and scientific meetings. Ensure quality assurance and regulatory compliance and participate in or lead development of new processes and functional procedures. Attend scientific meetings and continuing education programs and remain current on scientific advances in the animal health industry and veterinary profession. What You Need to Succeed (Minimum Qualifications) DVM or PhD in an animal health-related field preferred. An MS with relevant experience will be considered. An advanced degree (PhD) in parasitology in addition to a DVM is desirable. Five or more years of experience in product development within or closely associated with the pharmaceutical industry preferred. Demonstrated ability to organize and manage multiple projects simultaneously with strong attention to detail. Knowledge of applicable global, national, and federal regulations governing parasiticide product evaluation. Working knowledge of word processing and spreadsheet software. Self-motivated, with the ability to work and learn independently. Excellent written and verbal communication skills. What Will Give You a Competitive Edge (Preferred Qualifications) Basic understanding of research and development processes. Experience acting as a strategist and facilitator to advance clinical programs. Proven experience working with regulatory authorities. Strong understanding and working knowledge of GCP, GLP, GMP, and quality systems. Demonstrated ability to collaborate effectively with external partners and CROs. Evidence of achievement across key competencies including Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision. Additional Information Location: Global Headquarters, Indianapolis, IN (Hybrid) Travel: 10-20% domestic, with possible international travel Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
    $67k-95k yearly est. Auto-Apply 5d ago
  • Senior Clinical Research Associate (level dependent on experience)

    CTI Clinical Trial Services 3.7company rating

    Clinical research associate job in Indianapolis, IN

    Senior Clinical Research Associate (home based) (Level dependent on experience) To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
    $62k-97k yearly est. 60d+ ago
  • Study Coordinator II BioA

    Labcorp 4.5company rating

    Clinical research associate job in Greenfield, IN

    We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery. Essential Job Duties: * Writes Study Protocols, Methods and Reports * With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information * Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines. * With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams. * Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines. * Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner. * Supports report production processes through finalization * Assists with archiving of study related materials * Drives/Maintains Study and Client Communications * Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies. * Proactively communicates and interacts with study team, other departments, and clients as applicable. * Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate. * Support PM's and Scientists with preparing for and attends routine client visits. * With support manages data transfer to clients as requested. * Drives/Contributes to Process Improvement/Adherence * Participates in the development and maintenance of standard report/table formats as needed. * Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed. * Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements. * Study/Timeline Management * With support plans, prioritizes, and manages own workload and multiple responsibilities. * With support uses project tracking systems, as appropriate. * Manages standard projects and study designs, and drives to increase study load over time. * Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable. * Demonstrates active engagement with study progress/timelines. * Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment. * Other related duties as assigned Minimum Required: * Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education * Ability to learn/utilize word processing software, database, spreadsheet, and specialized software * Excellent communication and interpersonal skills * Excellent attention to detail * Ability to prioritize, organize, and manage time Application Window - 1/21 thru 1/31/2026 Pay Range: $24 - $25 per hour All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $24-25 hourly Auto-Apply 6d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Indianapolis, IN

    Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Duties include but not limited to: Ability to understand and follow institutional SOPs. Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Assist with planning and creation of appropriate recruitment materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Attend Investigator meetings as required. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Assist in the creation and review of source documents. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Patient Coordination Prescreen study candidates Obtain informed consent per Care Access Research SOP Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Bilingual in Spanish-preferred How We Work Together Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic. Travel: Regularly planned travel within the region will be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly 10d ago
  • Clinical Research Coordinator

    Indiana Hemophilia & Thrombosis Center 4.3company rating

    Clinical research associate job in Indianapolis, IN

    About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in related field required. Minimum 1 year of related experience required. Valid Indiana Driver's license and automobile insurance required. All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.
    $47k-67k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator

    Innovative Hematology, Inc.

    Clinical research associate job in Indianapolis, IN

    Job Description About IHI At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families. What You Will Do As a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. The Opportunity Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator. Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI. Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits. Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol. Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Participate in internal quality assurance; review monitor reports for trends across studies. Requirements Minimum Associate's degree in related field required. Minimum 1 year of related experience required. Valid Indiana Driver's license and automobile insurance required. All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role. Benefits IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics. IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology, Inc. is an Equal Opportunity Employer.
    $40k-59k yearly est. 28d ago
  • Clinical Research Assistant

    Actalent

    Clinical research associate job in Indianapolis, IN

    Job Title: Clinical Research AssistantJob Description We are seeking a dedicated Clinical Research Assistant to join our dynamic team in a lab setting. The primary responsibility of this role is to process blood samples in accordance with strict research protocols. This position is integral in ensuring that samples are processed, stored, and shipped correctly, sometimes requiring specific temperatures and labeling methods. The role operates in a fast-paced environment and is not patient-facing. Responsibilities + Process blood samples according to research protocols. + Ensure samples are stored and shipped per specific protocol requirements. + Maintain accurate labeling and documentation of specimens. + Work efficiently in a fast-paced laboratory environment. + Coordinate with other Clinical Research Assistants to ensure timely processing. Essential Skills + Experience in laboratory or healthcare settings, particularly in sample processing (1-2 years required). + Proficiency in specimen processing and labeling. + High School Diploma. Additional Skills & Qualifications + Research experience is a plus. + Experience in clinical trials and oncology is advantageous. Work Environment The position is based in a laboratory alongside two other Clinical Research Assistants. The environment is fast-paced and requires strong organizational skills to manage multiple tasks and ensure timely processing of samples according to protocols. The standard work hours are 8:00-5:00, with occasional extended hours needed to accommodate patient visits. The schedule offers flexibility, allowing for compensation of hours worked by leaving early on another day. Job Type & Location This is a Contract to Hire position based out of Indianapolis, IN. Pay and Benefits The pay range for this position is $18.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Indianapolis,IN. Application Deadline This position is anticipated to close on Feb 2, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $18-20 hourly 8d ago
  • Full-Time Dialysis Clinical Coordinator

    Rendevor Dialysis

    Clinical research associate job in Plainfield, IN

    Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need. What s In It For You? Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees. We offer an extremely generous package including: Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data) Fantastic employee benefit package Employer contribution to H.S.A. F.S.A. tax savings benefits A 4% dollar-for-dollar company match to the 401k plan with immediate vesting A generous PTO accrual program A PTO cash-out provision Tuition reimbursement program Employee referral bonus program Robust employee recognition and appreciation program Quality employee training and development programs Several holidays paid at time and a half Annual holiday gift bags for all employees Comprehensive Medical Benefits Vision Dental STD/LTD/Voluntary Life Accident, Critical Illness and Hospital Indemnity Plans Pet Insurance Discounted auto and home insurance Discounted legal services program Employer-paid life insurance for 1x employee salary Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members Complimentary year-long weight loss program Health & Wellness Program with gift card giveaways What You ll Do: The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments. The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel. The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc. As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements. Reports to the Regional Director as assigned. This dialysis unit is located in: Plainfield, IN, within Plainfield Correctional Facility This dialysis unit operates: Monday - Saturday from 5:00 am - 4:30 pm you will also cover the following dialysis unit located in: This dialysis unit is located in: Indianapolis, IN within Marion County Jail This dialysis unit operates: Operates Monday/Wednesday/Friday (shift depends on the number patients) As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.) Minimum Qualifications Education and Experience Graduation from an Accredited Nursing School or Equivalent Current RN License for Indiana & current CPR certification (or within three months of hire) One year of Hemodialysis RN experience is required Previous management experience preferred Required Skills and Competencies Ability to read, write, speak, understand and satisfactorily communicate in English. Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc. Ability to quickly learn a variety of technical systems and equipment Essential Duties and Responsibilities: Leadership In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures. Leads, coaches, and guides other clinical teammates, depending on unit size. May be required to monitor clinical teammate in-servicing and skills checks. Delegates tasks as necessary to maximize time and efficiency. Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication. Ensures company policies and procedures are maintained for continuity across the company. Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team. Participates in onboarding, training, and educating new hires. Ensures teammates have been properly in-serviced and checked off on skills. Staffing Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc. Maintains contact with PRN bench staff, coordinating requirements for needed schedules Facilitates staff development, training, and monthly education. Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed. Participates in employee appreciation events and planning, based on provided budget from Regional Director. In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates. Communicates staffing needs with RD and Talent Partner. Depending on unit size, may be required to participate in interviews and candidate selection. Encourages employee referrals and may be asked to contact referrals provided by staff. Clinical Delivers safe and effective patient care of all treatment modalities Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards. Actively participates in patient education, and ensures teammates follow same protocols. Takes ownership of lab collections and documentation. Applies critical thinking and time management skills. Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care. Depending on unit size and requirements, may be involved with patient care review meetings. Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies. Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request. Takes ownership of unit safety, cleanliness, and infection control As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc. Monitors and assures that the patients receive adequate medical attention while in the dialysis unit. Maintains the integrity of all protected health information. Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same. Supervises medical records to ensure complete documentation. Engages in constant learning and research of dialysis practices. Continuous Quality Improvement/Quality Assurance & Performance Improvemen Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed. Assists or may be responsible for the monthly completion of the Rendevor Application requirements. Ensures adequate resources for supporting the CQI/QAPI process as applicable. Communication (internal and external) Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc. May be required to attend and participate in facility meetings. Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications. Maintains an open-door policy to communicate with teammates. Maintains professionalism and privacy of confident information. Payroll Records both arrival and departure time via ADP s time and attendance system, following the guidelines outlined by Human Resources. Assists new hires in accessing the time system and demonstrates proper log in/out procedures. If assigned, approves timesheets of unit teammates in ADP. Accounting Timely and accurate review and submission of treatment rosters within two days of month end. Inventory/Supplies Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule. Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand. Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department. Business Development Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties. Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor. General Promotes and implements the Company s mission, vision, and core values. Displays excellent and professional written/verbal communication skills. Always maintains a professional demeanor; keeps an open door policy. Operates with a high level of responsiveness in providing information and deliverables to supervisors. Demonstrates a high degree of self-motivation and willingness to improve. Openly receives and promptly acts upon any feedback from supervisors, peers, clients. Volunteers to assist colleagues when necessary and assist with various projects as assigned. Reports any incidents to Regional Director. Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements. Must maintain RN license, CPR and a clean background. Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications. Adheres to all company and departmental policies and procedures. Maintains regular and predictable attendance and punctuality. Other duties as assigned. Supervision: This position will report to the Regional Director. This position will supervise clinical team members. Background Check: The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made. Work Environment: This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.) Rendevor Dialysis is an Equal-Opportunity Employer.
    $44k-63k yearly est. 34d ago
  • Full-Time Dialysis Clinical Coordinator

    CDI Health

    Clinical research associate job in Plainfield, IN

    Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need. Whats In It For You? Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees. We offer an extremely generous package including: Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data) * Fantastic employee benefit package * Employer contribution to H.S.A. * F.S.A. tax savings benefits * A 4% dollar-for-dollar company match to the 401k plan with immediate vesting * A generous PTO accrual program * A PTO cash-out provision * Tuition reimbursement program * Employee referral bonus program * Robust employee recognition and appreciation program * Quality employee training and development programs * Several holidays paid at time and a half * Annual holiday gift bags for all employees * Comprehensive Medical Benefits * Vision * Dental * STD/LTD/Voluntary Life * Accident, Critical Illness and Hospital Indemnity Plans * Pet Insurance * Discounted auto and home insurance * Discounted legal services program * Employer-paid life insurance for 1x employee salary * Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members * Complimentary year-long weight loss program * Health & Wellness Program with gift card giveaways What Youll Do: * The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments. * The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel. * The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc. * As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements. * Reports to the Regional Director as assigned. This dialysis unit is located in: * Plainfield, IN, within Plainfield Correctional Facility This dialysis unit operates: * Monday - Saturday from 5:00 am - 4:30 pm you will also cover the following dialysis unit located in: This dialysis unit is located in: * Indianapolis, IN within Marion County Jail This dialysis unit operates: * Operates Monday/Wednesday/Friday (shift depends on the number patients) As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.) Minimum Qualifications Education and Experience * Graduation from an Accredited Nursing School or Equivalent * Current RN License for Indiana & current CPR certification (or within three months of hire) * One year of Hemodialysis RN experience is required * Previous management experience preferred Required Skills and Competencies * Ability to read, write, speak, understand and satisfactorily communicate in English. * Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc. * Ability to quickly learn a variety of technical systems and equipment Essential Duties and Responsibilities: Leadership * In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures. * Leads, coaches, and guides other clinical teammates, depending on unit size. * May be required to monitor clinical teammate in-servicing and skills checks. * Delegates tasks as necessary to maximize time and efficiency. * Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication. * Ensures company policies and procedures are maintained for continuity across the company. * Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team. * Participates in onboarding, training, and educating new hires. * Ensures teammates have been properly in-serviced and checked off on skills. Staffing * Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc. * Maintains contact with PRN bench staff, coordinating requirements for needed schedules * Facilitates staff development, training, and monthly education. * Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed. * Participates in employee appreciation events and planning, based on provided budget from Regional Director. * In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates. * Communicates staffing needs with RD and Talent Partner. * Depending on unit size, may be required to participate in interviews and candidate selection. * Encourages employee referrals and may be asked to contact referrals provided by staff. Clinical * Delivers safe and effective patient care of all treatment modalities * Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards. * Actively participates in patient education, and ensures teammates follow same protocols. * Takes ownership of lab collections and documentation. * Applies critical thinking and time management skills. * Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care. * Depending on unit size and requirements, may be involved with patient care review meetings. * Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies. * Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request. * Takes ownership of unit safety, cleanliness, and infection control * As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc. * Monitors and assures that the patients receive adequate medical attention while in the dialysis unit. * Maintains the integrity of all protected health information. * Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same. * Supervises medical records to ensure complete documentation. * Engages in constant learning and research of dialysis practices. Continuous Quality Improvement/Quality Assurance & Performance Improvemen * Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed. * Assists or may be responsible for the monthly completion of the Rendevor Application requirements. * Ensures adequate resources for supporting the CQI/QAPI process as applicable. Communication (internal and external) * Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc. * May be required to attend and participate in facility meetings. * Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications. * Maintains an open-door policy to communicate with teammates. * Maintains professionalism and privacy of confident information. Payroll * Records both arrival and departure time via ADPs time and attendance system, following the guidelines outlined by Human Resources. * Assists new hires in accessing the time system and demonstrates proper log in/out procedures. * If assigned, approves timesheets of unit teammates in ADP. Accounting * Timely and accurate review and submission of treatment rosters within two days of month end. Inventory/Supplies * Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule. * Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand. * Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department. Business Development * Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties. * Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor. General * Promotes and implements the Companys mission, vision, and core values. * Displays excellent and professional written/verbal communication skills. * Always maintains a professional demeanor; keeps an open door policy. * Operates with a high level of responsiveness in providing information and deliverables to supervisors. * Demonstrates a high degree of self-motivation and willingness to improve. * Openly receives and promptly acts upon any feedback from supervisors, peers, clients. * Volunteers to assist colleagues when necessary and assist with various projects as assigned. * Reports any incidents to Regional Director. * Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements. * Must maintain RN license, CPR and a clean background. * Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications. * Adheres to all company and departmental policies and procedures. * Maintains regular and predictable attendance and punctuality. * Other duties as assigned. Supervision: * This position will report to the Regional Director. * This position will supervise clinical team members. Background Check: The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made. Work Environment: This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.) Rendevor Dialysis is an Equal-Opportunity Employer.
    $44k-63k yearly est. 36d ago
  • Director - Clinical Research Scientist

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Indianapolis, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. Roles and Responsibilities of the Position: Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Reporting of adverse events as mandated by corporate patient safety. Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. Minimum Requirements: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. Additional Preferences: Breast cancer disease area knowledge. Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. Proven track record to interact externally and internally to support a global scientific and business strategy. Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. Strong communication, both written and oral. Ability to multi-task and shift priorities rapidly to meet target dates. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $259,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $151.5k-259.6k yearly Auto-Apply 6d ago
  • Clinical Research Manager

    Pharmavise Corporation

    Clinical research associate job in Indianapolis, IN

    Job Description . The Clinical Research Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP/ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders. Key Responsibilities: Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases. Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities. Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards. Develop and maintain project timelines, budgets, and resource plans. Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators. Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports. Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing. Manage vendor and CRO relationships, including contract negotiations and performance monitoring. Track and report on study metrics and provide regular updates to senior leadership. Oversee the preparation and conduct of audits and regulatory inspections. Minimum Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (Master's or Ph.D. preferred). Minimum of 5-7 years of experience in clinical research, including 2+ years in a managerial or supervisory role. In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements. Proven experience managing Phase I-IV trials across multiple therapeutic areas. Strong project management, leadership, and team coordination skills. Excellent written and verbal communication abilities. Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms). Ability to travel up to 20% as needed. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
    $65k-100k yearly est. 8d ago
  • Study Coordinator II BioA

    Labcorp 4.5company rating

    Clinical research associate job in Greenfield, IN

    We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery. **Essential Job Duties:** + Writes Study Protocols, Methods and Reports + With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information + Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines. + With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams. + Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines. + Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner. + Supports report production processes through finalization + Assists with archiving of study related materials + Drives/Maintains Study and Client Communications + Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies. + Proactively communicates and interacts with study team, other departments, and clients as applicable. + Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate. + Support PM's and Scientists with preparing for and attends routine client visits. + With support manages data transfer to clients as requested. + Drives/Contributes to Process Improvement/Adherence + Participates in the development and maintenance of standard report/table formats as needed. + Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed. + Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements. + Study/Timeline Management + With support plans, prioritizes, and manages own workload and multiple responsibilities. + With support uses project tracking systems, as appropriate. + Manages standard projects and study designs, and drives to increase study load over time. + Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable. + Demonstrates active engagement with study progress/timelines. + Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment. + Other related duties as assigned **Minimum Required:** + Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education + Ability to learn/utilize word processing software, database, spreadsheet, and specialized software + Excellent communication and interpersonal skills + Excellent attention to detail + Ability to prioritize, organize, and manage time **Application Window** - 1/21 thru 1/31/2026 **Pay Range** : $24 - $25 per hour All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. **Benefits:** Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here (************************************************************** . **Labcorp is proud to be an Equal Opportunity Employer:** Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. **We encourage all to apply** If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (**************************************************** or contact us at Labcorp Accessibility. (Disability_*****************) For more information about how we collect and store your personal data, please see our Privacy Statement (************************************************* .
    $24-25 hourly 6d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Indianapolis, IN

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Duties include but not limited to: Ability to understand and follow institutional SOPs. Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Assist with planning and creation of appropriate recruitment materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Attend Investigator meetings as required. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Assist in the creation and review of source documents. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Patient Coordination Prescreen study candidates Obtain informed consent per Care Access Research SOP Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Bilingual in Spanish-preferred How We Work Together Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic. Travel: Regularly planned travel within the region will be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly Auto-Apply 20d ago
  • Clinical Research Assistant

    Actalent

    Clinical research associate job in Indianapolis, IN

    Job Title: Clinical Research AssistantJob Description We are seeking a dedicated Clinical Research Assistant to join our dynamic team in a lab setting. The primary responsibility of this role is to process blood samples in accordance with strict research protocols. This position is integral in ensuring that samples are processed, stored, and shipped correctly, sometimes requiring specific temperatures and labeling methods. The role operates in a fast-paced environment and is not patient-facing. Responsibilities * Process blood samples according to research protocols. * Ensure samples are stored and shipped per specific protocol requirements. * Maintain accurate labeling and documentation of specimens. * Work efficiently in a fast-paced laboratory environment. * Coordinate with other Clinical Research Assistants to ensure timely processing. Essential Skills * Experience in laboratory or healthcare settings, particularly in sample processing (1-2 years required). * Proficiency in specimen processing and labeling. * High School Diploma. Additional Skills & Qualifications * Research experience is a plus. * Experience in clinical trials and oncology is advantageous. Work Environment The position is based in a laboratory alongside two other Clinical Research Assistants. The environment is fast-paced and requires strong organizational skills to manage multiple tasks and ensure timely processing of samples according to protocols. The standard work hours are 8:00-5:00, with occasional extended hours needed to accommodate patient visits. The schedule offers flexibility, allowing for compensation of hours worked by leaving early on another day. Job Type & Location This is a Contract to Hire position based out of Indianapolis, IN. Pay and Benefits The pay range for this position is $18.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Indianapolis,IN. Application Deadline This position is anticipated to close on Feb 2, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $18-20 hourly 8d ago
  • Full-Time Dialysis Clinical Coordinator

    Rendevor Dialysis

    Clinical research associate job in Plainfield, IN

    Job Description Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need. What's In It For You? Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees. We offer an extremely generous package including: Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data) Fantastic employee benefit package Employer contribution to H.S.A. F.S.A. tax savings benefits A 4% dollar-for-dollar company match to the 401k plan with immediate vesting A generous PTO accrual program A PTO cash-out provision Tuition reimbursement program Employee referral bonus program Robust employee recognition and appreciation program Quality employee training and development programs Several holidays paid at time and a half Annual holiday gift bags for all employees Comprehensive Medical Benefits Vision Dental STD/LTD/Voluntary Life Accident, Critical Illness and Hospital Indemnity Plans Pet Insurance Discounted auto and home insurance Discounted legal services program Employer-paid life insurance for 1x employee salary Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members Complimentary year-long weight loss program Health & Wellness Program with gift card giveaways What You'll Do: The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments. The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel. The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc. As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements. Reports to the Regional Director as assigned. This dialysis unit is located in: Plainfield, IN, within Plainfield Correctional Facility This dialysis unit operates: Monday - Saturday from 5:00 am - 4:30 pm you will also cover the following dialysis unit located in: This dialysis unit is located in: Indianapolis, IN within Marion County Jail This dialysis unit operates: Operates Monday/Wednesday/Friday (shift depends on the number patients) As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.) Minimum Qualifications Education and Experience Graduation from an Accredited Nursing School or Equivalent Current RN License for Indiana & current CPR certification (or within three months of hire) One year of Hemodialysis RN experience is required Previous management experience preferred Required Skills and Competencies Ability to read, write, speak, understand and satisfactorily communicate in English. Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc. Ability to quickly learn a variety of technical systems and equipment Essential Duties and Responsibilities: Leadership In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures. Leads, coaches, and guides other clinical teammates, depending on unit size. May be required to monitor clinical teammate in-servicing and skills checks. Delegates tasks as necessary to maximize time and efficiency. Holds “team huddles” to discuss unit goals and objectives and delivers pertinent corporate communication. Ensures company policies and procedures are maintained for continuity across the company. Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team. Participates in onboarding, training, and educating new hires. Ensures teammates have been properly in-serviced and checked off on skills. Staffing Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc. Maintains contact with PRN bench staff, coordinating requirements for needed schedules Facilitates staff development, training, and monthly education. Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed. Participates in employee appreciation events and planning, based on provided budget from Regional Director. In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates. Communicates staffing needs with RD and Talent Partner. Depending on unit size, may be required to participate in interviews and candidate selection. Encourages employee referrals and may be asked to contact referrals provided by staff. Clinical Delivers safe and effective patient care of all treatment modalities Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards. Actively participates in patient education, and ensures teammates follow same protocols. Takes ownership of lab collections and documentation. Applies critical thinking and time management skills. Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care. Depending on unit size and requirements, may be involved with patient care review meetings. Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies. Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request. Takes ownership of unit safety, cleanliness, and infection control As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc. Monitors and assures that the patients receive adequate medical attention while in the dialysis unit. Maintains the integrity of all protected health information. Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same. Supervises medical records to ensure complete documentation. Engages in constant learning and research of dialysis practices. Continuous Quality Improvement/Quality Assurance & Performance Improvemen Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed. Assists or may be responsible for the monthly completion of the Rendevor Application requirements. Ensures adequate resources for supporting the CQI/QAPI process as applicable. Communication (internal and external) Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc. May be required to attend and participate in facility meetings. Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications. Maintains an open-door policy to communicate with teammates. Maintains professionalism and privacy of confident information. Payroll Records both arrival and departure time via ADP's time and attendance system, following the guidelines outlined by Human Resources. Assists new hires in accessing the time system and demonstrates proper log in/out procedures. If assigned, approves timesheets of unit teammates in ADP. Accounting Timely and accurate review and submission of treatment rosters within two days of month end. Inventory/Supplies Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule. Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand. Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department. Business Development Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties. Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor. General Promotes and implements the Company's mission, vision, and core values. Displays excellent and professional written/verbal communication skills. Always maintains a professional demeanor; keeps an “open door” policy. Operates with a high level of responsiveness in providing information and deliverables to supervisors. Demonstrates a high degree of self-motivation and willingness to improve. Openly receives and promptly acts upon any feedback from supervisors, peers, clients. Volunteers to assist colleagues when necessary and assist with various projects as assigned. Reports any incidents to Regional Director. Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements. Must maintain RN license, CPR and a clean background. Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications. Adheres to all company and departmental policies and procedures. Maintains regular and predictable attendance and punctuality. Other duties as assigned. Supervision: This position will report to the Regional Director. This position will supervise clinical team members. Background Check: The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made. Work Environment: This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.) Rendevor Dialysis is an Equal-Opportunity Employer.
    $44k-63k yearly est. 31d ago
  • Director - Clinical Research Scientist - Immunology/Gastroenterology Development

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Indianapolis, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. * Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule * Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. * Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. * Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. * Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements * An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD * 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences * Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills * Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills * Previous GI drug development experience * Pediatric drug development experience * Oral/written communication/listening skills are essential * Strong relationship-building and interaction skills with peers and management * Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $108k-148k yearly est. Auto-Apply 18d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Greenwood, IN?

The average clinical research associate in Greenwood, IN earns between $42,000 and $103,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Greenwood, IN

$66,000
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