Clinical Research Regulatory Coordinator

Clinical Research Regulatory Coordinator

Join our community
Revive Research Institute has an excellent opportunity available within our Clinical Research Department as a Research Regulatory Coordinator. If you are looking for challenging work and meaningful advancement, then you should consider a career with Revive Research Institute.

Where you fit in
The Research Regulatory Coordinator leads, coordinates and oversees 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. Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments/interventions.

Duties:

• Manages regulatory activities for all stages of clinical trials for assigned department(s). Prepares and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
• Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
• Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/ARO
• Prepare and submit start-up regulatory packets to Sponsor and IRB
• Oversee study start-up activities to including reporting and communicating with stakeholders on a regular basis
• 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
• Assist in submission of Investigational New Drug (IND) applications including amendments and reporting
• Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits
• 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. (Required)
• 1-2 years: Minimum of one (1) year of clinical research experience required. Prior regulatory experience preferred.

Your exceptional skills

• Ability to be detail oriented
• Ability to be organized
• Ability to perform basic computer functions
• Ability to use customer service skills to provide an exceptional experience
• Ability to work effectively within a team environment
• Must be able to prioritize tasks; work well under stress, meet aggressive timelines, and problem solve to quickly and tactfully manage challenging situations concerning customer groups
• Must be willing to work flexible hours if needed
• Must demonstrate intermediate competency in the use of the Internet and the following Microsoft applications: Word, Excel, Outlook
• Personal Characteristics
• Ability to communicate effectively both orally and in writing

Your life with Revive Research Institute
You work hard to provide our patients with the exceptional care, and you deserve benefits to match. Revive Research Institute offers a unique employment package that encompasses not only your day-to-day job, but also your career.