Clinical Research Regulatory Specialist

Baylor Scott & White Health•Dallas, TX

About The Position

The Clinical Research Regulatory Specialist supports clinical research by developing protocol-specific documents and reports. This role focuses on developing, submitting, maintaining, filing, and reporting regulatory documents. The goal is to comply with all internal, external, and federal policies and regulations for research involving human subjects. This position also offers regulatory guidance to internal clinical research programs to ensure compliance with all relevant policies, procedures, and regulations.

Requirements

Proven written and oral communication skills.
Proven leadership skills in project management, including project management tools and techniques.
Exceptional computer skills, including Microsoft Office, Excel and PowerPoint.
Ability to manage time reactive projects in order to meet deadlines.
Excellent ability to establish and maintain effective working relationships.
Associate's or 2 years of work experience above the minimum qualification
3 Years of Experience

Responsibilities

Prepares, facilitates, and coordinates the process for accurate and timely IRB application submissions. This includes protocol revisions or amendments for new treatments, administrative changes, subject population changes, funding, recruitment, site changes, informed consent changes, or dual enrollment. These are for IRB-approved protocols as required by federal regulations and internal policy.
Ensure all documents are complete and meet the IRB's requirements before submission. Follow up, communicate, and facilitate responses to queries from the IRB, Sponsor, and other committees after their review.
Coordinates the preparation and submission of consent forms. Ensures compliance with federal, state, and local biomedical research regulations. Obtains Sponsor approval of consent forms before submitting to the IRB.
Facilitates and coordinates the timely submission of regulatory documents and IRB submissions. Partners with research nurses, clinical research coordinators, and investigators to prepare regulatory documents. Ensures that regulatory binders are audited and maintained.
Tracks workload and status of pending protocols and related documents. This ensures efficient customer service for the Research team.
Participates in quality assurance (QA) and control programs for projects and patient data, as needed. Oversees QA initiatives for the department. Helps research staff and managers during sponsor and FDA audits.
Facilitates investigator-initiated research by ensuring all regulatory requirements are met. This includes ensuring trial registration, results, and reporting are completed on time, consistent with federal regulations.