Project Coordinator (Site Activation and Maintenance)

Medpace; Cincinnati (OH); On-site; USD 48,000 - 64,000; Full time

Job summary

Medpace is seeking full-time, office-based Project Coordinators to join our Site Activation and Maintenance (SAM) team. This role supports clinical trial management and the study start-up process, working independently and with a team to achieve shared goals.

Responsibilities include coordinating with sites to collect essential documents, maintaining TMF quality, assembling start-up submissions, and tracking timelines across departments.

Qualifications

• Bachelor's degree required (preferably in Life Sciences).
• Some healthcare or clinical research experience preferred.
• Excellent organizational and prioritization skills with strong communication.
• Proficiency with Microsoft Office applications.
• Great attention to detail and written/spoken communication.

Responsibilities

• Communicate with research sites to collect essential documents before screening.
• Maintain and review trial documents in the TMF.
• Assemble regulatory start-up submissions, including IRB submissions.
• Maintain study start-up timelines with internal and external teams.
• Gain exposure to Oncology/Hematology, Cardiovascular, and Metabolic areas.
• Provide guidance to team members to ensure regulatory compliance.
• Review regulations to develop proactive regulatory solutions.
• Participate in SAM training program modules and mentoring.

Skills

Organizational skills

Prioritization

Communication skills

Attention to detail

Education

Bachelor's degree in Life Sciences or related field

Tools

Microsoft Office

Job description

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Project Coordinators to join our Site Activation and Maintenance (SAM) team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. If you want to build on your foundational knowledge and take the next step in your clinical research career, then this is the opportunity for you.

Responsibilities

• Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
• Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
• Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
• Maintain timelines for study start-up through both internal and external collaboration;
• Gain exposure to multiple therapeutic areas including but not limited to Oncology/Hematology, Cardiovascular, and Metabolic;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements; and
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM

• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;
• Gain exposure to real-world tasks through a robust mentoring program; and
• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Qualifications

• Bachelor's degree required (preferably in a Life Sciences field);
• Some experience within the healthcare or clinical research field preferred;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills.

Travel: None