Experienced Study Start-Up Coordinator

Medpace; Cincinnati (OH); On-site; USD 50,000 - 70,000; Full time

Job summary

A clinical research organization is seeking a full-time Regulatory Submissions Coordinator in Cincinnati, Ohio. This role involves coordinating regulatory submissions, ensuring compliance, and communicating with research sites. Ideal candidates will have a Bachelor's degree in Life Sciences and at least 1-5 years of experience in study coordination or the pharmaceutical industry. Strong organizational and communication skills are essential. Join a team dedicated to advancing clinical trials with your expertise.

Qualifications

• Minimum of 1-5+ years of experience as a study coordinator or related pharmaceutical experience required.
• Excellent at organizing and prioritizing tasks.
• Strong written and oral communication skills.

Responsibilities

• Communicate with research sites to collect essential documents for clinical trials.
• Maintain ongoing quality review of trial documents.
• Organize and assemble regulatory submissions.
• Ensure compliance with regulations and requirements.

Skills

Organizational skills

Oral and written communication skills

Attention to detail

Microsoft Office knowledge

Education

Bachelor's degree in a Life Sciences field

Job description

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions 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 at Medpace. We have openings for clinical research coordinators to best match your experience level. If you want to build on your foundational knowledge and your previous experience to develop and grow your career even further, 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;
• 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

Medpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence based learning & 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; and
• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Qualifications

• A minimum of a Bachelor\'s degree is required (preferably in a Life Sciences field);
• 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office; and
• Great attention to detail and excellent oral and written communication skills.

Travel: None

Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

What To Expect Next: A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.