Clinical Research Regulatory Coordinator

Have you been looking for a place to grow your skillset? Or perhaps you are looking for a place to develop your career surrounded by a diverse group where employees feel a sense of belonging.

At Gastro One we are championing the power of inclusivity and a people first mentality. We hope to improve the human experience – from our patients to our colleagues.

If you are interested in joining our culture, we’re looking for a Clinical Research Regulatory Coordinator to lead, coordinate, and oversee regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently.

A little about us:

Gastro One is a team of gastroenterologists and allied health professionals with a proven track record of providing excellent care that families can count on. We specialize in treating the full range of digestive diseases and endeavor to provide exceptional care, for every patient, every time.

We are powered by One GI®, a true collaboration of the very best clinical and business minds – which enables us to focus on what’s truly important – our patients.

Snapshot of Daily Duties

• Manage regulatory activities for all stages of clinical trials. Prepare and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
• Maintain a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provide guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
• Prepare and submit start-up regulatory packets to Sponsor and IRB.
• Assist with study start-up activities to including reporting and communicating with Sponsor, IRB, and individual sites.
• Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution.
• Monitor approval status of open studies by completing timely reviews.
• Maintain master files of all regulatory-related documents.
• Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits.

The Must Haves

• High School Diploma or equivalent required.
• Associate Degree/Bachelor’s Degree: Bachelor’s or Associate degree in a related field. An applicable degree may be nursing, life sciences, business administration, or health care administration or research administration.
• 1-2 years: Minimum of one (1) yeas of clinical research experience required. Prior regulatory experience preferred.

The Perks

• 401k with match
• Tuition reimbursement
• Competitive health & supplemental benefits