Study Start-Up Coordinator (CRC Experience)

About the Role

Our clinical operations activities are growing rapidly, and we are seeking Clinical Research Coordinators to join our Study Start-up 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. This position is based in Cincinnati, OH.

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;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Site Activation & Maintenance (SAM) Training Program

Medpace training programs are curated to educate and support experienced associates, as well as those new to the industry. The SAM Training Program embraces evidence-based learning and development models to advance professional learning and employee performance. In the program, you will:

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

Requirements

• Bachelor's degree required, preferably in a Life Sciences field;
• 1-2 years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office;
• No travel required.

Benefits

• Competitive compensation programs that recognize and reward performance;
• Comprehensive health, wellness, retirement, and PTO benefits;
• Office-based culture with occasional WFH flexibility for eligible positions after training;
• Company-sponsored social events;
• Defined career paths with clear advancement opportunities;
• Industry-renowned onboarding and training programs designed to accelerate professional development;
• Ongoing training and continuous learning opportunities throughout your career;
• An environment that encourages employees to influence change, contribute ideas, and grow quickly.

Please note benefits may vary based on country.