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Clinical research associate jobs in Indiana

- 56 jobs
  • Clinical Trial Project Manager - Patient Engagement Delivery Lead

    Connexus Technology, LLC 3.5company rating

    Clinical research associate job in Indianapolis, IN

    Patient Engagement Delivery Lead / Direct Portfolio Project Manager Level: Senior Associate Manager Department: Patient Engagement; Engagement & Diversity Delivery Overview: We are seeking a Patient Engagement Delivery Lead / Direct Portfolio Project Manager to support one of our clients in identifying and delivering innovative approaches/vendors/third parties to implement and support recruitment and retention strategies for diverse patient populations. This role is critical to accelerate enrollment and improve retention across trials/programs. The Delivery Lead ensures that the chosen approaches/vendors meet or exceed the expectations of therapeutic recruitment and retention strategies, optimizing their value. Strong communication skills and the ability to collaborate with colleagues in the Patient Engagement organization is essential to optimize strategy delivery, including content generation, vendor performance, best practices, and issue escalation. The Delivery Lead oversees the financial aspects of the strategy, enhancing effective approaches, and pausing ineffective ones. Additionally, the role involves collaborating within Clinical Capabilities and across Clinical Design Delivery and Analytics (CDDA) to share best practices, drive efficiency, and influence key stakeholders. The Delivery Lead promotes a culture of quality, inspection readiness, and timely decision-making to support the delivery of Lilly's assets. Primary Responsibilities Execute recruitment and retention strategies for clinical trials and programs, making informed decisions, mitigating risks, and collaborating with peers and leadership to ensure optimal delivery. Provide leadership in managing trial-related activities, ensuring efficiency, compliance, and adherence to regulatory/ERB requirements. Support documentation management and ensure compliance with clinical trial record-keeping requirements. Work closely with internal teams and stakeholders to streamline clinical processes and improve trial outcomes. Foster a culture of partnership and shared learning to identify best practices and standardize approaches for efficiency and optimized value. Apply innovation and lessons learned in real time. Qualifications Bachelor's degree in a scientific or health-related field (required). Minimum 3 years of experience in clinical trials, patient engagement, or drug development. At least 3 years of project management experience leading cross-functional or clinical initiatives. Strong understanding of clinical trial operations, compliance, and regulatory frameworks. Excellent communication, organization, and collaboration skills. Proven ability to lead and influence teams, anticipate challenges, and drive solutions. Passion for advancing patient diversity, inclusion, and access in clinical research.
    $66k-106k yearly est. 4d ago
  • Clinical Research Coordinator

    Medasource 4.2company rating

    Clinical research associate job in Indianapolis, IN

    Clinical Research Coordinator (CRC) Duration: 6+ month contract Schedule: Monday-Friday, ~40 hours/week (some flexibility based on clinic or study needs) Coordinates both sponsor-initiated and investigator-initiated oncology-focused clinical trials. Responsible for identifying, screening, and enrolling eligible participants; ensuring compliance with study protocols; and serving as the primary liaison between the study team, participants, and sponsors. Key Responsibilities Study Coordination & Participant Management Screen and identify potential study participants by reviewing medical records against protocol eligibility criteria. Obtain informed consent from study participants and ensure all documentation is properly completed before study initiation. Schedule and coordinate research-related services such as infusions, imaging, and other procedures. Collaborate with insurance coordinators and research nurses to confirm coverage for standard-of-care procedures. Maintain participant scheduling, visit confirmation, and reimbursement tracking through OnCore and Nimblify. Data Collection & Regulatory Compliance Conduct study visits, including interviews and assessments related to medication compliance, quality of life, and adverse events. Record and document protocol deviations and collaborate with the study team to resolve any issues. Extract and enter data from source documents into case report forms and assist with SAE reporting. Ensure compliance with GCP standards, IRB, FDA, and institutional regulations. Team & Sponsor Collaboration Coordinate with sponsors, clinical research specialists, and investigators to ensure study integrity and resolve queries. Prepare for monitoring visits and participate in teleconferences and investigator meetings. Educate ancillary departments and staff on protocol requirements and assist in the development of study-specific order sets. Administrative & Operational Support Maintain accurate records, calendars, and participant statuses in OnCore. Contribute to SOPs, site policies, and process improvements to enhance research operations. Provide direction and oversight to Clinical Research Specialists (CRS), Clinical Data Coordinators (CDC), and lab technicians. Qualifications Education: Bachelor's degree in science or a health-related field and at least 2 years of clinical research experience OR Associate's degree in science or a health-related field and 3 years of clinical research experience Preferred: SOCRA or ACRP Clinical Research Certification Skills & Abilities: Strong organizational and communication skills (written and verbal) Ability to interpret complex scientific and clinical information Proficient in OnCore and Microsoft Office Strong attention to detail and ability to multitask in a fast-paced clinical setting Excellent interpersonal skills with the ability to interact with participants, families, and multidisciplinary teams Knowledge of research documentation, case report forms, and study protocols Additional Notes This position functions autonomously and requires regular interaction with principal investigators and study staff. The role is critical to participant safety and protocol compliance; attention to regulatory standards is essential. Physical requirements include working in clinic settings, sitting for extended periods, and maintaining composure in a fast-paced environment.
    $40k-57k yearly est. 1d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate job in Indiana

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K
    $53k-84k yearly est. 60d+ 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. 22d ago
  • Sr. Clinical Research Associate- CST

    Ire

    Clinical research associate job in Indiana

    Senior Clinical Research Associate 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 We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing: Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. Your Profile: Advanced degree in a relevant field such as life sciences, nursing, or medicine. Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license 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
    $61k-97k yearly est. Auto-Apply 53d 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
  • Clinical Trials - Clinical Data Associate

    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. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. **Please note, this is a hybrid position 3 days onsite/2 days remote** Purpose: This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. Primary Responsibilities: Portfolio Strategy, Planning and Delivery Define Lilly business requirements for the study/program for vendors to deliver Ensure that data management timeline and results are delivered to scope, cost, and time objectives Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker) Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets) Define and approve data quality and submission outputs and results Project Management Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives Specifies the data collection tools and technology platforms for the trial/program Drive standards decisions, implementation and compliance for the study/program Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios Facilitate/assimilate integration of disparate data sources into datasets for decision making Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables Communication Act as primary communication point for all data management activities related to a clinical study. Report out status of data management milestones and data quality. Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database. Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions. Partner with cross-functional team members to ensure trial success through robust oversight/review. Process Improvement Continually seek and implement means of improving processes to reduce cycle time and decrease work effort Represent data sciences' processes in multi-functional initiatives. Actively engage in shared learning across the Data and Analytics organization. Work with partners to increase vendor/partner efficiencies Minimum Qualification Requirements: Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences (or Bachelor's degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...) Other Information/Additional Preferences: Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles Demonstrated ability to lead development of creative data solutions to address clinical development challenges Passionate about improving technological solutions using new technologies Society of Clinical Data Management certification Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, ‘R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS. Experience with the following: Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical) Strong therapeutic/scientific knowledge in the field of research Knowledge of medical terminology Domestic and International travel may be required Ability to balance multiple activities, prioritize and manage ambiguity Demonstrated exemplary teamwork/interpersonal skills Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment. 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 $63,000 - $140,800 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
    $63k-140.8k yearly Auto-Apply 48d ago
  • Clinical Research Coordinator I

    Objectivehealth 3.7company rating

    Clinical research associate job in South Bend, IN

    Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
    $41k-61k yearly est. 20d ago
  • Clinical Research Coordinator II (Indianapolis, IN)

    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 into 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. Benefits & Perks * 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: ********************************
    $44k-62k yearly est. 48d ago
  • Clinical Research Coordinator

    Francisan Health

    Clinical research associate job in Indianapolis, IN

    Franciscan Health Indianapolis Campus 8111 S Emerson Ave Indianapolis, Indiana 46237 The Clinical Research Coordinator II provides services related to the implementation and completion of clinical research protocols. This includes tasks such as obtaining informed consent for clinical trial participation, training other research team members, and completing all protocol-specified procedures. WHO WE ARE With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the largest Catholic health care systems in the Midwest. Franciscan Health takes pride in hiring coworkers that provide compassionate, comprehensive care for our patients and the communities we serve. WHAT YOU CAN EXPECT * Collaborate with Research Financial Analyst to ensure research billing is accurate. * Conduct a thorough and ongoing informed consent process and document appropriately. * Conduct clinical trials that involve human subjects, according to written protocols and departmental standards while adhering to Good Clinical Practice (GCP) Guidelines. * Create and complete valid source documentation, per GCP requirements. * Document and maintain all research activities, including patient visits. * Identify key elements of subject safety including, IRB oversight, study documentation, and event reporting. * Identify and explain key protocol elements to study subjects and perform study tasks as dictated by protocol. * Maintain research certification on a biannual or triannual basis, as appropriate. * Monitor adverse events and report serious events to the research sponsor, according to written protocols and departmental standards. * Recruit and screen potential subjects for inclusion in clinical trials, according to written protocols. * Respond to data queries issued by the study sponsor or sponsor's representative in a timely manner. QUALIFICATIONS * Associate's degree required (Health Administration, Business, Health Science, Nursing/Patient Care preferred) * Bachelor's Degree preferred * 3 years research experience required * IATA training within 6 months of hire date required * Certified Clinical Research Professional (CCRP) within 1.5 years required * Certified Clinical Research Coordinator (CCRC) within 1.5 years required TRAVEL IS REQUIRED: Never or Rarely EQUAL OPPORTUNITY EMPLOYER It is the policy of Franciscan Alliance to provide equal employment to its employees and qualified applicants for employment as otherwise required by an applicable local, state or Federal law. Franciscan Alliance reserves a Right of Conscience objection in the event local, state or Federal ordinances that violate its values and the free exercise of its religious rights. Franciscan Alliance is committed to equal employment opportunity. Franciscan provides eligible employees with comprehensive benefit offerings. Find an overview on the benefit section of our career site, jobs.franciscanhealth.org.
    $40k-59k yearly est. 5d ago
  • Clinical Research Coordinator II

    Dm Clinical Research Group

    Clinical research associate job in Indianapolis, IN

    Job Details Indianapolis - Indianapolis, INClinical Research Coordinator II The Clinical Research Coordinator II will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff 2Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required; Bachelor's degree preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
    $40k-59k yearly est. 24d 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. 10d ago
  • Clinical Coordinator

    Allergy Partners 4.1company rating

    Clinical research associate job in Indianapolis, IN

    Job Details 54-07-Indianapolis - Indianpolis, IN 54 C Indy - Indianapolis, IN; 54-01-Avon - Avon, IN; 54-02-Shadeland - Indianapolis, INDescription JOB SUMMARY: coordinates patient care with physician, assists physician with assessment, gives medication pursuant to physician order and assists with administrative duties that further patient care. Responsibilities include, but are not limited to, the following: Clinical Support Greets patient and escorts them from the waiting room to exam rooms; prepares patients for exam or treatment; takes vital signs. Provides assistance to physician when requested. Performs Spirometry and other breathing tests as ordered. Prepares and maintains supplies and equipment for treatments, including sterilization. Performs patient education when appropriate. Completes appropriate documentation in patients medical record. Calls in prescriptions as ordered by physician or nurse practitioner. Performs allergy prick testing and/or intradermal testing as ordered by physician. Administers allergy injections to shot patients as set forth on physician approved schedule. Monitors patients medical status for possible adverse reaction following receipt of allergy injection. Maintains emergency equipment, including oxygen, code kit, suction, etc. Answers patient-related telephone calls and respond according to clinical protocol. Follows up to obtain referrals and insurance authorization as requested and needed. Maintains clinical supply stock and medication samples. Other Maintains patient confidentiality; complies with HIPAA and compliance guidelines established by the practice. Maintains detailed knowledge of practice management and other computer software as it relates to job functions. Attends CPR, OSHA, HIPAA, and OIG training programs as required. Attends all regular meetings. Performs all other tasks and projects assigned by the Manager. Qualifications EDUCATIONAL REQUIREMENTS: High school degree required Registered Nurse License required QUALIFICATIONS AND EXPERIENCE: At least one year of experience in clinical assisting Comfortable using email and interacting with Internet applications Knowledge of practice management and word processing software Good communication skills Neat, professional appearance
    $48k-61k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Iterative Scopes Inc.

    Clinical research associate job in New Albany, IN

    Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Reports To: Manager, Clinical Research Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities * Administratively and clinically manage industry sponsored clinical trials. * Adhere to Research SOP's, Good Clinical Practices, and the study protocols. * Assist in patient recruitment by performing detailed chart reviews and patient interviews. * Discuss study protocols with patients and verify the informed consent documentation. * Review medical history of patient against inclusion/exclusion criteria of studies. * Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. * Schedule all patient research visits and procedures consistent with protocol requirements. * Dispense study medication, collect vital signs, and perform ECGs. * Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. * Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. * Function in a clinical role by conducting clinical research studies. * Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes. * Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. * Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. * Act as a resource for other staff members regarding investigational issues or guidelines. * Coordinate the availability and distribution of medications for patients in a timely manner. * Perform phlebotomy for lab work as required and completes all necessary forms. * Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. * Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. * Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects. * Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. * Plan, implement, and maintain data collection and analysis systems in support of the research protocol. * Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. * Facilitate assigned clinical trial from start to finish. * Screen participants for all studies independently. * Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. * Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. * Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies * Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated General * Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. * Incorporate a leadership mindset to your role. * Comply with One GI procedures, policies, and regulations relevant to your role. * Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) * Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. * Computer skills - good working knowledge of MS office. * Ability to communicate effectively with others, both verbally and in writing. * Proven ability to manage time, meet deadlines and prioritize. * Able to maintain standards and professionalism during periods of fluctuating workloads. * Provide professional service to direct customers of One GI in all interactions. * Build effective working relationships with other team members. * Manage daily tasks to ensure business needs are consistently met. Education and Qualifications * High School Diploma or equivalent required. * Associates degree in a clinical or scientific related discipline required. * Bachelor's degree preferred. * One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required. * Previous GI trials experience preferred. * Clinical experience in an office or hospital setting. * Research experience or equivalent. * Must maintain current licensure and/or certification. * Basic Life Support certification required. * Knowledge of medical terminology, anatomy, physiology, and pathophysiology. * Familiarity with health care systems, regulations, policies, and functions. * Understanding of clinical research documentation standards. * Knowledge of equipment, supplies, and materials needed for medical treatment. * Understanding of basic laboratory procedures including phlebotomy, preparation, and screening * Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails. * Registered Nurse with five (5) years experience required. * BSN preferable. * Membership in local, state and national societies is encouraged. * Understanding of Code of Federal Regulations for Human Subjects. * Certified in GCP's and HSP. * Periodic local travel to other practice locations on an as-needed basis. * Phlebotomy experience preferred. 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 requiredto speak and hear. Understand/comprehend English as well as read/follow written English instructions. This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening. Work Environment This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at anytime with or without notice. Accommodations Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with theneeds of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
    $40k-58k yearly est. Auto-Apply 46d ago
  • Clinical Research Coordinator

    Iterative Health

    Clinical research associate job in New Albany, IN

    Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Reports To: Manager, Clinical Research Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities Administratively and clinically manage industry sponsored clinical trials. Adhere to Research SOP's, Good Clinical Practices, and the study protocols. Assist in patient recruitment by performing detailed chart reviews and patient interviews. Discuss study protocols with patients and verify the informed consent documentation. Review medical history of patient against inclusion/exclusion criteria of studies. Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. Schedule all patient research visits and procedures consistent with protocol requirements. Dispense study medication, collect vital signs, and perform ECGs. Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. Function in a clinical role by conducting clinical research studies. Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes. Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. Act as a resource for other staff members regarding investigational issues or guidelines. Coordinate the availability and distribution of medications for patients in a timely manner. Perform phlebotomy for lab work as required and completes all necessary forms. Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects. Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. Plan, implement, and maintain data collection and analysis systems in support of the research protocol. Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. Facilitate assigned clinical trial from start to finish. Screen participants for all studies independently. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated General Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. Incorporate a leadership mindset to your role. Comply with One GI procedures, policies, and regulations relevant to your role. Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. Computer skills - good working knowledge of MS office. Ability to communicate effectively with others, both verbally and in writing. Proven ability to manage time, meet deadlines and prioritize. Able to maintain standards and professionalism during periods of fluctuating workloads. Provide professional service to direct customers of One GI in all interactions. Build effective working relationships with other team members. Manage daily tasks to ensure business needs are consistently met. Education and Qualifications High School Diploma or equivalent required. Associates degree in a clinical or scientific related discipline required. Bachelor's degree preferred. One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required. Previous GI trials experience preferred. Clinical experience in an office or hospital setting. Research experience or equivalent. Must maintain current licensure and/or certification. Basic Life Support certification required. Knowledge of medical terminology, anatomy, physiology, and pathophysiology. Familiarity with health care systems, regulations, policies, and functions. Understanding of clinical research documentation standards. Knowledge of equipment, supplies, and materials needed for medical treatment. Understanding of basic laboratory procedures including phlebotomy, preparation, and screening Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails. Registered Nurse with five (5) years experience required. BSN preferable. Membership in local, state and national societies is encouraged. Understanding of Code of Federal Regulations for Human Subjects. Certified in GCP's and HSP. Periodic local travel to other practice locations on an as-needed basis. Phlebotomy experience preferred. 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 requiredto speak and hear. Understand/comprehend English as well as read/follow written English instructions. This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening. Work Environment This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at anytime with or without notice. Accommodations Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with theneeds of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
    $40k-58k yearly est. Auto-Apply 46d ago
  • EMS Clinical Coordinator

    Beacon Health System 4.7company rating

    Clinical research associate job in Elkhart, IN

    Reports to the Director of Emergency Care Services and interfaces with the Emergency Medical Services (EMS) Medical Director. Responsibilities include analyzing training and education needs of the pre-hospital care givers in this region and developing, designing and implementing training and educational programs. Ensure high level of cooperation between the Hospital, pre-hospital care givers and the emergency room staff. MISSION, VALUES and SERVICE GOALS * MISSION: We deliver outstanding care, inspire health, and connect with heart. * VALUES: Trust. Respect. Integrity. Compassion. * SERVICE GOALS: Personally connect. Keep everyone informed. Be on their team. Ensures the training and education needs of the pre-hospital care givers in this region are met in accordance with the Hospital's standards and applicable laws and regulations by: * Conducting education needs analysis in conjunction with appropriate management and staff personnel in order to determine clinical and/or classroom educational needs. * Planning, designing, coordinating and conducting training and educational programs in pre-hospital areas. * Designing, preparing, evaluating and updating lesson plans, lectures, tests and other necessary training/educational materials, programs and courses as necessary. * Teaching current pre-hospital care givers and/or new trainees by conducting classroom training and providing individual instruction. * Preparing necessary administrative/support materials such as program schedules, student evaluations, time/attendance records, etc. * Directing on-the-job instruction by coordinating the activities of trainees in a variety of clinical settings. * Monitoring trainee progress and performance; also providing instruction and counseling as necessary and making appropriate recommendations to line management. Supports the management team by: * Serving as a regional resource person for clinical and training matters and ensuring that a cooperative atmosphere is maintained between the Hospital and pre-hospital care givers. * Improving public awareness of Emergency Medical Services (EMS) system in the region through guest lectures, interviews, articles and programming. * Serving as a liaison between public and pre-hospital care givers. * Planning, designing and coordinating continuing education workshops in pre-hospital emergency areas. * Assisting other instructors in conducting classes as assigned. Performs other functions to maintain personal competence and contribute to the overall effectiveness of the department by: * Assisting with community outreach, educational activities as appropriate or as assigned. * Completing other job-related assignments and special projects as directed. ORGANIZATIONAL RESPONSIBILITIES Associate complies with the following organizational requirements: * Attends and participates in department meetings and is accountable for all information shared. * Completes mandatory education, annual competencies and department specific education within established timeframes. * Completes annual employee health requirements within established timeframes. * Maintains license/certification, registration in good standing throughout fiscal year. * Direct patient care providers are required to maintain current BCLS (CPR) and other certifications as required by position/department. * Consistently utilizes appropriate universal precautions, protective equipment, and ergonomic techniques to protect patient and self. * Adheres to regulatory agency requirements, survey process and compliance. * Complies with established organization and department policies. * Available to work overtime in addition to working additional or other shifts and schedules when required. Commitment to Beacon's six-point Operating System, referred to as The Beacon Way: * Leverage innovation everywhere. * Cultivate human talent. * Embrace performance improvement. * Build greatness through accountability. * Use information to improve and advance. * Communicate clearly and continuously. Education and Experience * The knowledge, skills and abilities as indicated below are normally acquired through the successful completion of an approved EMT or paramedic training program. Current Indiana certification as an EMT and a Paramedic is required; also must be approved as an Indiana State Emergency Management Agency Primary Instructor. A minimum of two to three years of related clinical experience as an EMT or a Paramedic is required in order to gain the necessary depth of experience and knowledge. Knowledge & Skills * Requires well-developed knowledge of current training and adult education philosophies, techniques, programs, tools, equipment, etc. * Requires the analytical skills necessary to conduct training needs analysis, design and prepare programs, etc. * Demonstrates the high-level interpersonal skills necessary to interface effectively with all levels of Hospital team members and meet productively with various non-hospital based pre-hospital care givers. * Requires the ability to deal with and maintain control in stressful situations; also requires flexibility and creativity to meet changing needs of expanding programs. * Requires the ability to work autonomously. * Requires the ability to teach EMTs, EMT-Ps, other healthcare professionals and the public the appropriate aspects of emergency care (formal and informal teaching). * Requires the communication skills - - and the ability to collaborate - - that are necessary to deal effectively with the public and representatives of other healthcare services (for example, in the implementation of EMS programs). * Participates with local and state agencies in developing, coordinating and monitoring emergency preparedness activities. Working Conditions * Works in a patient care environment requiring physical exertion, frequent changes in job demands, certain undesirable patient care activities and possible exposure to communicable disease, bio-hazards and radiation. * Operates patient-related equipment. * Work schedule may vary in order to meet the needs of the department. Physical Demands * Requires the physical ability and stamina (i.e. to walk/stand for prolonged periods of time, push carts/wheelchairs up to 50 pounds, to position/lift patients at a maximum of 35 pounds unassisted, over 35 pounds requires assistance, provide CPR, etc.) to perform the essential functions of the position. * Requires the fine motor skills necessary for the manipulation of high-tech equipment; also requires the visual and manual dexterity to perform the essential functions of the position.
    $50k-67k yearly est. 20d ago
  • Dr. Baessler's Clinic Roomer (Certified Medical Assistant)

    Beacon Orthopaedic Partners MSO LLC

    Clinical research associate job in Fishers, IN

    Job Description The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner. Type: Full Time Location: Fishers, IN office Travel Required: 1 day a week to Zionsville, IN and Fishers, IN Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record. Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic. Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary. Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients. Prepares exam and treatment rooms with necessary instruments based on physician and patient needs. Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary. Places a high priority on and maintains strict confidentiality in all situations. Participates in professional development activities and maintains applicable professional affiliations and certifications as required. Attends and participates in required organizational meetings and committees as requested. Perform additional related duties as assigned. Education, Experience, and Certification/License Requirements: Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification. Working Conditions/Physical Requirements: Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
    $32k-45k yearly est. 14d ago
  • Clinical Research Assistant

    Velocity Clinical Research

    Clinical research associate job in Valparaiso, IN

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
    $32k-46k yearly est. Auto-Apply 51d ago
  • Clinical Project Manager

    Connexus Technology, LLC 3.5company rating

    Clinical research associate job in Indianapolis, IN

    Connexus Technology is seeking an experienced Direct Portfolio Project Manager to support a project with one of our clients in their Clinical Trials Patient Engagement Team, driving innovative strategies to enhance patient involvement in research. This role plays a critical part in optimizing clinical trial recruitment, retention, and overall project management. The ideal candidate will have a strong understanding of clinical trial processes, protocols, and regulatory best practices, combined with expertise in project management. This is a Connexus Technology opportunity to work with one of our clients in their Clinical Trial Patient Engagement Team, supporting innovative approaches to patient-centered clinical research. Key Responsibilities: Recruitment & Retention Strategy: Develop and implement strategies to enhance patient recruitment and retention for clinical trials and programs. Project Management Oversight: Provide leadership in managing trial-related projects, ensuring efficiency, compliance, and adherence to regulatory requirements. Cross-Functional Collaboration: Work closely with internal teams and stakeholders to streamline clinical processes and improve trial outcomes. Record & Retention Compliance (For Record & Retention Roles): Support documentation management and ensure compliance with clinical trial record-keeping requirements. Administrative Project Support (For Project Management Roles): Assist with administrative tasks related to project coordination and execution. Critical thinking skills, enabling the understanding of repeatable processes, of nuances, and being able to determine what next steps need to be based on fact-dependent parameters Comfortable operating in a deadline-driven environment, able to understand and implement prioritization based on defined processes and associated deadlines Coachability - taking direction and feedback well and applying learning from it appropriately and retaining the instruction and learning that is provided. Qualifications 5+ years of project management experience in Clinical Trials Patient Engagement Strong technical skills (Excel, SharePoint, Ariba, Fiori, SAP) and knows which to use for which task Strong knowledge of clinical trial protocols, processes, and regulatory best practices Skilled at developing and executing patient recruitment & retention strategies Demonstrated project leadership, cross-functional collaboration, and process improvement experience Quick learner and independent self-starter who can self-manage and self-teach Proven ability to handle high-volume, repeatable processes with accuracy and efficiency Strong critical thinking skills to determine next steps based on fact-dependent parameters Comfortable operating in a deadline-driven environment with the ability to prioritize tasks based on defined processes and timelines Collaborative team player who also works well independently Strong interpersonal and communication skills
    $74k-107k yearly est. 1d ago
  • Dr. Baessler's Clinic Roomer (Certified Medical Assistant)

    Beacon Orthopaedic Partners MSO LLC

    Clinical research associate job in Anderson, IN

    Job Description The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner. Type: Full Time Location: Fishers, IN office Travel Required: 1 day a week to Zionsville, IN and Fishers, IN Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record. Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic. Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary. Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients. Prepares exam and treatment rooms with necessary instruments based on physician and patient needs. Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary. Places a high priority on and maintains strict confidentiality in all situations. Participates in professional development activities and maintains applicable professional affiliations and certifications as required. Attends and participates in required organizational meetings and committees as requested. Perform additional related duties as assigned. Education, Experience, and Certification/License Requirements: Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification. Working Conditions/Physical Requirements: Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
    $32k-45k yearly est. 14d ago

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