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

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Gas City, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary The Clinical Research Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans. Key Responsibilities 1. Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups. Lead data analyses and health outcomes research to address customer questions. Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners. Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements. Support training of sales, medical, and patient support teams. Lead definition of Patient Journey and contribute clinical perspective to patient programs. Participate in relevant professional and industry associations. 2. Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication. Address unsolicited scientific inquiries in alignment with medical governance standards. Support scientific meetings, advisory boards, symposia, and other expert engagements. Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts. Build and maintain relationships with key opinion leaders and scientific societies. Represent the company at medical congresses and support scientific booth activities. Contribute to data analyses, publication development, and Clinical Trial Registry reporting. 3. Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams. Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements. Maintain up‑to‑date understanding of clinical and competitive data. Provide regional clinical insights to inform development plans and study protocols. 4. Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication. Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out. Support investigator/site training and address study‑related medical questions. Oversee local safety monitoring and adverse event follow‑up. Review investigator‑initiated trial (IIT) proposals as needed. Ensure global alignment of Phase 3b/4 and applicable early‑phase studies. 5. Regulatory Support Contribute to development and review of local labeling and labeling changes. Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities. Participate in risk management planning with global and local teams. 6. Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape. Provide scientific training to clinical study teams and act as a protocol subject‑matter expert. Represent the organization at medical congresses and contribute to medical budget planning. Seek opportunities for external scientific engagement. 7. Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports. Contribute to recruitment, diversity, and retention efforts when applicable. Participate in committees, Six Sigma initiatives, and cross‑functional projects. Model leadership behaviors and serve as an ambassador for patients and the company. Basic Qualifications An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience Additional Preferences Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information) Ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $177k-308k yearly Auto-Apply 11d ago
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  • Lead Clinical Research Associate

    Oracle 4.6company rating

    Clinical research associate job in Indianapolis, IN

    With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
    $70.6k-141.2k yearly 11d ago
  • Clinical Research Associate (Start Up) - Cross Therapeutic - Columbus, OH

    Ire

    Clinical research associate job in Indianapolis, IN

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

    Pharmavise Corporation

    Clinical research associate job in Indianapolis, IN

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

    Icon Central Laboratories

    Clinical research associate job in Indianapolis, IN

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

    Parexel 4.5company rating

    Clinical research associate job in Indianapolis, IN

    PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $145k-182k yearly est. 3d ago
  • Clinical Scientist

    Eliassen Group 4.7company rating

    Clinical research associate job in Indianapolis, IN

    **Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
    $130k-150k yearly 12d ago
  • Principle Research Scientist - Clinical Operations

    Elanco 4.9company rating

    Clinical research associate job in Indianapolis, IN

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

    CTI Clinical Trial Services 3.7company rating

    Clinical research associate job in Indianapolis, IN

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

    Lilly 4.3company rating

    Clinical research associate job in Indianapolis, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. **Roles and Responsibilities of the Position:** Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. + Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. + Reporting of adverse events as mandated by corporate patient safety. + Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. + Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. + Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. + Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. **Minimum Requirements:** + An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). + 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. **Additional Preferences:** + Breast cancer disease area knowledge. + Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. + Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. + Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. + Proven track record to interact externally and internally to support a global scientific and business strategy. + Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. + Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. + Strong communication, both written and oral. + Ability to multi-task and shift priorities rapidly to meet target dates. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $259,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly
    $73k-118k yearly est. 11d ago
  • Clinical Project Manager

    Global Channel Management

    Clinical research associate job in Indianapolis, IN

    Clinical Project Manager needs 5+ years experience Clinical Project Manager requires: Onsite Clinical Project management MS Project, SAP, IMPACT etc. Accurately forecast and track direct expenses for clinical budgets Document key team information and clinical decisions in Chorus custom tracking and communication database Manage clinical operational risks and their impact to the timelines and budgets of clinical studies, including critical path activities Select and manage external network of vendors to ensure on time and on budget clinical project deliverables Establish and manage Clinical vendor expectations, performance, and delivery Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward Partner with regulatory and medical to ensure safety management and monitoring processes are implemented Provide input into molecule development, clinical regulatory and safety strategy Manage global cross-functional communication and escalations to ensure alignment on delivery and execution Utilize clinical operations process knowledge to drive decision making. Participate in review of clinical database specifications and utilization
    $78k-115k yearly est. 60d+ ago
  • Divisional Government Grants and Research Coordinator (DHQ)

    Salvation Army USA 4.0company rating

    Clinical research associate job in Indianapolis, IN

    The Salvation Army Mission Statement: The Salvation Army, an international movement, is an evangelical part of the universal Christian church. Its message is based on the Bible. Its ministry is motivated by the love of God. Its mission is to preach the gospel of Jesus Christ and to meet human needs in His name without discrimination. Salary Range Starting at: $65,000.00 annually : As the Divisional Government Grants and Research Coordinator, you will be responsible for researching federal, state, and local government funding opportunities and preparing high-quality grant proposals to secure funding for organizational programs and initiatives. This role requires exceptional writing skills, strong attention to detail, and the ability to interpret government guidelines, compliance requirements, and program regulations; advising program staff and Corps officers about grant requirements and expectations; to ensure comprehensive coordination of grant-related support for Programs, Corps and Service Extension Units across the Indiana Division, so that the mission of The Salvation Army is effectively carried out. What You Will Do: * Research federal, state, and local grant opportunities through government portals (such as Grants.gov, SAM.gov, and state/local portals). * Identify grants that align with organizational mission, programs, and strategic objectives. * Track application deadlines, eligibility requirements, and submission protocols. * Write, format, and edit government grant applications, narratives, and supporting documents. * Ensure proposals comply with government requirements, including formatting, data reporting, and regulatory standards. * Participate in budget development with finance teams to create compliant, realistic, and funder-aligned budgets. * Prepare all required attachments, certifications, and supplemental materials. * Work with directors, program managers, and financial staff to align proposals with organizational capacity and goals. * Support planning meetings and grant strategy sessions. * Communicate grant requirements, timelines, and responsibilities to internal teams. * Provide support as needed to Corps officers and staff in writing and/or proofreading their grant proposals * Ensure grant applications are approved by Divisional Finance Board and grant agreements are signed by DFB leadership * Maintain calendar of grant application and reporting deadlines to ensure timeliness and effective utilization of funding opportunities * Other tasks as assigned by leadership Minimum Qualifications: The requirements listed below are representative of the minimal education, experience, skills, and/or abilities required for this position. Education: Bachelor's degree in social work, public administration, nonprofit management, or other closely related fields from an accredited institution. Background Checks: Position requires a background check to be completed, and all background check results will be reviewed. Experience: A minimum of three years' grant writing experience in a nonprofit environment, including demonstrated success in managing and coordinating grant writing projects, securing grant awards, and completing timely grant reports. Certifications: Must have a valid driver's license and maintain The Salvation Army Driver's qualification standard; must complete Safe from Harm training within the first 90 days of employment. Skills/Abilities: * Excellent writing, verbal communication, time management, and organizational skills. * Able to speak, write and understand English in a manner sufficient for effective communication with leadership, field personnel, and funders. * Computer proficiency with Microsoft products and ability to learn electronic reporting systems. * Strong understanding of federal, state, and local government funding processes. * Excellent research, writing, and editing skills with superior attention to detail. * Ability to interpret government regulations, RFPs, and funding guidelines. * Experience with logic models, program design, and outcome measurement. Supervisory Responsibility: None The physical requirements described here are representative of those that must be met by an employee to successfully perform the duties of this job. Reasonable accommodation may be provided to enable individuals to perform the essential functions of this job. Physical Requirements Include: * Good speaking, hearing and vision ability, and excellent manual dexterity * Lifting, pulling, and pushing of materials up to 25 pounds * May require bending, squatting, walking. * May require standing for extended Travel: Occasional travel may be needed to meet with funders, attend meetings, and visit TSA facilities in the Division. Working Conditions: Work is performed in an office environment. May require occasional weekend or evening work. All employees recognize that The Salvation Army is a church and agree that they will do nothing as an employee of The Salvation Army to undermine its religious mission. The Salvation Army is an equal opportunity employer. Candidates who are back-to-work, US Veterans, people with disabilities, people who have been impacted by the justice system, and/or people without a college degree are encouraged to apply. This job description should not be interpreted as all inclusive. It is intended to identify the essential functions and requirements of the position. Other job-related responsibilities and tasks may be assigned. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions. Why Work with Us? If you're ready for a career doing meaningful work with a discernable impact, keep reading. The Salvation Army's brand promise is to Do the Most Good - and it's our employees that help us get there. At every level and in every discipline, you can have a real impact on your community through the work done inside our walls every day. If you work for us, you will be the hands and feet that enable us to help others. We are as impassioned about our employees as we are about our mission to preach the Gospel of Jesus Christ and help anyone in need in His name without discrimination. Our work culture reflects this quality, which makes our offices seriously great places to work. Just walk inside our doors and you'll quickly see that our employees are proud to support programs that make a difference. In addition to traditional Health, Wellness, RX and PTO benefits, see what our employees told us they most liked about working for the Indiana Division of TSA by responding to our most recent 2023 survey… * 91% are proud of their work to help meet the needs of people in their communities * 75% find their "Work Stress" manageable * 80% find their managers supportive during those times of stress * 89% appreciate the flexible work options they have in their position * 98% appreciate how they are allowed to use 4 sicks days as "Discretionary" * 99% appreciate the 11 paid holidays they receive each year See what our employees said when asked to rank the best reasons for working at the Indiana Division Salvation Army… * Helping People * Faith Centered Organization * Work Environment/ Co-Workers * Benefits
    $65k yearly Auto-Apply 34d ago
  • Specialist, Clinical Business Operations, Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research associate job in Indianapolis, IN

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $72.5k-90.6k yearly 60d+ ago
  • RN Oncology Clinical Trial Research Coordinator

    Ascension Health 3.3company rating

    Clinical research associate job in Indianapolis, IN

    **Details** + **Department: Research - Oncology** + **Schedule: Full Time Day - Monday - Friday 8-5** + **Hospital: Ascension St. Vincent** **Benefits** Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental leave & adoption assistance Tuition reimbursement Ways to give back to your community _Benefit options and eligibility vary by position. Compensation varies based on factors including, but not limited to, experience, skills, education, performance, location and salary range at the time of the offer._ **Responsibilities** Lead clinical research projects via study protocols and provide direct patient care for study participants. + Assist with the preparation, submission and management of internal/external compliance documentation at all stages of the research project. + Assist with the selection, education, testing, and monitoring of research project participants. Follow protocols and collaborate with other healthcare providers to ensure continuity of participant care. + Document patient care and study results using appropriate formats and systems. Communicate patient/study results on an on-going basis to research team. + Participate in quality assurance/improvement initiatives. Ensure compliance with applicable standards of care and regulatory requirements. **Requirements** Licensure / Certification / Registration: + Registered Nurse credentialed from the Indiana Board of Nursing obtained prior to hire date or job transfer date required. Education: + Diploma from an accredited school/college of nursing OR Required professional licensure at time of hire. **Additional Preferences** No additional preferences. **Why Join Our Team** Ascension St. Vincent in Indiana has been providing rewarding careers in healthcare for over 148 years. With 24 hospitals throughout the greater Indianapolis and Evansville areas, Ascension St. Vincent offers careers in a wide range of services including acute and long-term care, bariatrics, cancer care, cardiovascular services, emergency services, neuroscience, orthopedics, pediatric services, primary and urgent care, women's health services and more. Ascension is a leading non-profit, faith-based national health system made up of over 134,000 associates and 2,600 sites of care, including more than 140 hospitals and 40 senior living communities in 19 states. Our Mission, Vision and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make a positive impact in their community. Ascension careers are more than jobs; they are opportunities to enhance your life and the lives of the people around you. **Equal Employment Opportunity Employer** Ascension provides Equal Employment Opportunities (EEO) to all associates and applicants for employment without regard to race, color, religion, sex/gender, sexual orientation, gender identity or expression, pregnancy, childbirth, and related medical conditions, lactation, breastfeeding, national origin, citizenship, age, disability, genetic information, veteran status, marital status, all as defined by applicable law, and any other legally protected status or characteristic in accordance with applicable federal, state and local laws. For further information, view the EEO Know Your Rights (English) (************************************************************************************** poster or EEO Know Your Rights (Spanish) (**************************************************************************************** poster. As a military friendly organization, Ascension promotes career flexibility and offers many benefits to help support the well-being of our military families, spouses, veterans and reservists. Our associates are empowered to apply their military experience and unique perspective to their civilian career with Ascension. Please note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants. **E-Verify Statement** This employer participates in the Electronic Employment Verification Program. Please click the E-Verify link below for more information. E-Verify (****************************************
    $39k-59k yearly est. 11d ago
  • Study Coordinator II BioA

    Labcorp 4.5company rating

    Clinical research associate job in Greenfield, IN

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

    Azenta

    Clinical research associate job in Plainfield, IN

    Azenta Inc.At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and IntegrityJob TitleClinical Project ManagerJob Description How You'll Add Value The Clinical Project Manager within the Project Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services. What You'll Do Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements. Able to act efficiently in an environment with dynamic timelines and priorities. Accountable for the monitoring and reporting of performance metrics. Create required project plans. Implement and monitor progress against project plans and revise as necessary. Monitor project schedule and scope to ensure both remain on track. Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements. Participate in pre-sale discussion and client meetings as required. Actively participate in Azenta Life Sciences development through continuous process improvement, quality, and productivity. Mentor Client Coordinator as needed. Managing queries and resolutions. What You Will Bring Bachelor's degree in science or related field with a minimum of 1 year of experience in a regulated industry environment. OR High School Diploma or minimum of 5 years of experience in a regulated industry environment. Strong organizational skills and attention to detail. Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations. Demonstrated ability to complete long-range projects as assigned. Demonstrated ability to prioritize work, customers, internal and external demands. Your Working Conditions Hybrid - Indianapolis (aligned to company policy 4 days in office) . The Employee may occasionally work in an area with potentially infectious materials. The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated. EOE M/F/Disabled/VET If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ********************* for assistance. Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status. United States Base Compensation: $60,000.00 - $75,000.00 The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.
    $60k-75k yearly Auto-Apply 9d ago
  • Clinical Project Manager

    Azenta Inc.

    Clinical research associate job in Plainfield, IN

    Azenta Inc. At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity Job Title Clinical Project Manager Job Description How You'll Add Value The Clinical Project Manager within the Project Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services. What You'll Do Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements. Able to act efficiently in an environment with dynamic timelines and priorities. Accountable for the monitoring and reporting of performance metrics. Create required project plans. Implement and monitor progress against project plans and revise as necessary. Monitor project schedule and scope to ensure both remain on track. Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements. Participate in pre-sale discussion and client meetings as required. Actively participate in Azenta Life Sciences development through continuous process improvement, quality, and productivity. Mentor Client Coordinator as needed. Managing queries and resolutions. What You Will Bring * Bachelor's degree in science or related field with a minimum of 1 year of experience in a regulated industry environment. * OR High School Diploma or minimum of 5 years of experience in a regulated industry environment. * Strong organizational skills and attention to detail. * Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations. * Demonstrated ability to complete long-range projects as assigned. * Demonstrated ability to prioritize work, customers, internal and external demands. Your Working Conditions * Hybrid - Indianapolis (aligned to company policy 4 days in office) . * The Employee may occasionally work in an area with potentially infectious materials. * The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated. EOE M/F/Disabled/VET If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ********************* for assistance. Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status. United States Base Compensation: $60,000.00 - $75,000.00 The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.
    $60k-75k yearly 8d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Indianapolis, IN

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

    Community Health Network 4.3company rating

    Clinical research associate job in Indianapolis, IN

    Join Community Community Health Network was created by our neighbors, for our neighbors. Over 60 years later, “community” is still the heart of our organization. It means providing our neighbors with the best care possible, backed by state-of-the-art technology. It means getting involved in the communities we serve through volunteer opportunities and benefits initiatives. It means ensuring our dedicated caregivers can learn and grow to stay at the top of their fields and to better serve our patients. And above all, it means exceptional care, simply delivered - and we couldn't do it without you. Make a Difference The Sr. Clinical Research Coordinator is responsible for independently running and operating multiple research protocols in conjunction with the Principal Investigator and serves as a lead in the clinical research unit. • Determines facility and supply needs required for set-up and implementation of research protocols. • Assists in identifying study related procedures for the project budget. • Prepares for and is present for sponsor representative site visits. • Provides regional leadership for assigned research. • Be able to perform all of the duties of the Clinical Research Coordinator. • Trains and/or may supervise Clinical Research Assistants and/or Clinical Research Coordinators. • Assists with preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites in conjunction with the Clinical Research Manager. Your exceptional skills and qualifications • 2+ years\: Completion of a bachelor's or associate degree from an accredited nursing program (RN) plus a minimum of three (3) years oncology research experience OR • Completion of a bachelor's degree in a related field plus a minimum of three (3) years oncology research experience. • Must be a Certified Clinical Research Coordinator (CCRC-ACRP) or Certified Clinical Research Professional (CCRP-SoCRA) • Previous coordinator experience • Oncology research experience • Ability to be detail oriented • Ability to be organized • Ability to communicate effectively both orally and in writing with all levels of the organization • Ability to effectively use interpersonal skills • Ability to independently manage time and priorities • Ability to navigate EMRs • Ability to travel between locations • Ability to use patient care skills to provide an exceptional experience • Ability to utilize Microsoft Office Suite • Demonstrates compliance with hospital standards, policies and procedures • Ability to communicate effectively both orally and in writing
    $38k-51k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator

    Indiana Hemophilia & Thrombosis Center 4.3company rating

    Clinical research associate job in Indianapolis, IN

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

Learn more about clinical research associate jobs

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

The average clinical research associate in Noblesville, IN earns between $42,000 and $104,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Noblesville, IN

$66,000
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