Clinical Research Associate - Clinical Research Coordinator Experience
Medpace is seeking home-based Clinical Research Associates (CRAs) through our PACE® Training Program. This opportunity is ideal for clinical research professionals with at least one year of Clinical Research Coordinator experience.
About the Role
Through our PACE® Training Program, you will receive the training needed to become a fully resourced CRA. This role involves conducting site visits, monitoring activities, and ensuring compliance with protocols and regulatory requirements.
Responsibilities
- Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
- Communicate with medical site staff, including coordinators, clinical research physicians, and their site staff.
- Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
- Perform medical record and research source documentation verification against case report form data, including informing site staff of entry errors and ensuring adherence to good documentation practices.
- Communicate protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
- Perform on-site and virtual/remote monitoring activities with a risk-based monitoring approach through our integrated Clinical Trial Management System.
- Identify site deviations/deficiencies and recommend corrective/preventive actions to bring a site back into compliance and mitigate risks.
- Verify the investigator is enrolling only eligible subjects.
- Review regulatory documents, medical devices, and/or investigational product/drug accountability and inventory.
- Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting.
- Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement.
- Complete monitoring reports and follow-up letters, summarizing significant findings, deviations, deficiencies, and recommended actions.
Requirements
- Minimum of a Bachelor’s degree in a health or science-related field.
- Minimum of one year of experience as a Clinical Research Coordinator.
- Ability to travel 60-70% to locations nationwide; some visits may be conducted remotely.
- A valid driver’s license and the ability to drive to monitoring sites.
- Proficient knowledge of Microsoft Office.
- Strong communication and presentation skills.
- Detail-oriented with efficient time management.
Benefits
- Competitive travel bonus.
- Equity/Stock option program.
- Training completion and retention bonus.
- Annual merit increases.
- 401K matching.
- Opportunity to work from home with flexible work hours.
- Retain airline reward miles and hotel reward points.
- Home office furniture allowance, laptop, and mobile phone with hotspot for internet access.
- In-house travel agents, reimbursement for airline club membership, and TSA pre-check.
- Opportunities for leadership positions (e.g., Lead CRA, CRA Manager, Training and Development Manager).
- CRA training program (PACE®).
- Ongoing therapeutic training by in-house physicians who are medical and regulatory experts.
- In-house administrative support for all levels of CRA.
- Opportunity to work with an international team of CRAs.
- Comprehensive health, wellness, retirement, and PTO benefits.
- Office-based culture with occasional work-from-home flexibility for eligible positions after training.
- Company-sponsored social events and intramural sports.
About Medpace
Medpace is a full-service clinical contract research organization (CRO) providing phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through clinical research excellence. We leverage in-country regulatory and therapeutic expertise across major therapeutic areas, including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,500 people across 40+ countries.
Why Medpace?
- Purpose-Driven Work: Collaborate with physicians, scientists, and industry-leading experts committed to advancing medical therapeutics through clinical research.
- Collaborative Culture: Contribute to an interactive team environment that encourages decision-making, creative thinking, and continuous learning.
- Leadership Accessibility: Engage with leadership that is both accessible and approachable.
- Continuous Growth & Development:
- Office-based environment with on-site mentors.
- Defined career paths with clear advancement opportunities.
- Industry-renowned onboarding and training programs.
- Ongoing training and continuous learning opportunities.
- An environment that encourages employees to influence change and grow quickly.
Cincinnati Headquarters Experience
- A modern corporate campus designed to support collaboration and productivity.
- Multiple on-site dining options.
- Free on-site parking.
- Convenient access to on-site 24-7 fitness and wellness facilities.