Study Start-Up Coordinator – Clinical Research Coordinator Experience

Medpace, Inc.; Irving (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive health benefits

Office-based with on-site mentors

Defined career paths and onboarding

Job summary

Medpace is seeking a Regulatory Submissions Coordinator for the Study Start-up team in a full-time, office-based role in Dallas, TX. The position involves coordinating with sites to collect essential documents, managing TMF quality, and assembling regulatory submissions for IRBs and other authorities.

Ideal candidates have a life sciences degree and 1-5+ years’ study start-up or pharmaceutical experience, with strong organizational and communication skills and proficiency in Microsoft Office.

Qualifications

• Bachelor's degree required, preferably in Life Sciences.
• 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred.
• Excellent organization and communication skills; and
• Knowledge of Microsoft Office.

Responsibilities

• Communicate with research sites to collect essential documents before screening.
• Maintain and perform ongoing quality review of trial documents in TMF.
• Collect, review, organize, and assemble regulatory start-up submissions (IRB submissions included).
• Maintain timelines for study start-up through internal and external collaboration.
• Provide advice and guidance to team members to ensure regulatory compliance.
• Review regulations and guidance to develop proactive regulatory solutions.

Skills

Regulatory submissions

Study start-up

Documentation management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator 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. *This position is based in Dallas, TX.

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 otherprofessionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Qualifications

• Bachelor's degree required, preferably in a Life Sciences field;
• 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred;
• Excellent organization and communication skills; and
• Knowledge of Microsoft® Office

• Travel: None

  Supervisor Responsibilities: None

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting- edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace 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 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

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.