Clinical Research Regulatory Specialist

Baylor Scott & White Health•Dallas, TX

60d

About The Position

The Clinical Research Regulatory Specialist supports clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external and federal policies and regulations pertinent to research involving human subjects. This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures and regulations.

Requirements

EDUCATION - Associate's or 2 years of work experience above the minimum qualification
EXPERIENCE - 3 Years of Experience

Responsibilities

Prepares, facilitates and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB. Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research. Obtains Sponsor approval of consent form prior to submission to the IRB.
Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents. Ensures that regulatory binders are audited and maintained.
Tracks workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team.
Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed. Oversees QA initiatives for the department to support research staff and leaders during sponsor and FDA audits.
Facilitates investigator-initiated research by ensuring all regulatory requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a timely manner consistent with federal regulations.