Research Regulatory Associate I

Urology San Antonio•San Antonio, TX

14h

About The Position

The Research Regulatory Associate I 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 the development, submission, maintenance, filing, archival, and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations involving the research of human participants. In addition, this position also provides regulatory guidance and direction to internal clinical research programs and staff to ensure compliance with all applicable policies, procedures, and regulations.

Requirements

Development of protocol-specific documents and reports
Development, submission, maintenance, filing, archival, and reporting of regulatory documents
Achieve and maintain compliance with internal, external, and federal policies and regulations
Provide regulatory guidance and direction to internal clinical research programs and staff
Ensure compliance with all applicable policies, procedures, and regulations
Preparation and submission of Institutional Research Board (IRB) applications for protocol revisions or amendments
Adherence to standard operating procedures, sponsor/CRO requirements, FDA regulations, ICH guidelines, and good clinical practices
Ensuring completeness of documents and submission packets for IRB review
Maintaining subject and document confidentiality
Compliance with sponsor requirements, FDA regulations, GCP, ICH, HIPAA, IRB, and institutional policies and procedures
Responding to queries from IRB, Sponsor, and other committees
Producing error-free written documents and reports (cover letters, notes-to-file, memos)
Obtaining Sponsor approval for consent forms
Coordination of consent form preparation and submission
Coordination of regulatory document submission (hard copies and electronic binders)
Filing and maintaining logs within regulatory binders
Archival of clinical trial documents/records
Tracking workload and status of pending protocols and supporting documents
Interaction with internal and external personnel
Attending site initiation visits
Overseeing QA initiatives for the department
Ensuring all regulatory requirements are met for trial registration, results, and reporting
Coordination of multiple projects with competing priorities and deadlines

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 the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols.
Safeguards prior to sending to the IRB that all documents are complete and that the submission packet meets the IRB's submission requirements.
Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures.
Responses and assists with queries from the IRB, Sponsor, and other committees.
Produces error-free written documents and reports, such as cover letters, notes-to-file, and memos.
Obtains the Sponsor's approval for the consent form prior to submission to the IRB.
Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research.
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 to prepare regulatory documents.
Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records.
Tracks workload and status of pending protocols and associated supporting documents to provide efficient customer service to the Research team.
Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients, and attends site initiation visits.
Oversees the QA initiatives for the department to support research staff and leaders during Sponsor and FDA audits.
Ensures all regulatory requirements are met, including requirements for trial registration, results, and reporting in a timely manner consistent with federal regulations.
Coordinates multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volume.
Assists with all other duties as assigned