GENERAL SUMMARY/OVERVIEW STATEMENT:
The Center for Clinical Investigation (CCI) provide research support for the BWH investigator community. The CCI is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women's Hospital.
The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Mass General Brigham policies as well as extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines.
PRINCIPAL DUTIES & RESPONSIBILITIES:
Regulatory Coordination
• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies and offices.
• Prepares, maintains and organizes regulatory files for each assigned study in compliance federal and local regulations including study sponsor requirement, institutional requirements and good clinical practice guidelines.
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third-party auditors.
Compliance and Education
• Performs preparatory regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies. The compliance audit process includes but is not limited to:
o Communicating with Principal Investigator (PI) and designated study staff,
o Performing remote and onsite review of study regulatory and subject files,
o Providing education and study management support to the PI and research team,
o Providing a written report and assessment of noncompliance,
o Completing follow up to ensure corrective actions are implemented and the needs of the study staff are fully addressed.
• Perform Study Start Up Assessments of clinical research protocols prior to study initiation
• Conduct consultations pre-audit and as needed/requested with investigators and study staff on human subject research
• Provide human research education at MGB institutions to large and small groups as assigned
• Assist with the development of study management tools and study document templates for use by the MGB research community
• Assist with development of clinical research education, support, and outreach activities at MGB institutions
• Provide education, support/guidance, and resources to MGB research teams regarding all aspects of human subject research including:
o Clinical Trials.gov registration and reporting requirements
o Responsibilities of sponsor-investigators related to IND and IDE regulatory requirements and annual reporting to the FDA
Clinical Trial Management
• Expertise in project management related to tracking and managing assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
• Create and maintain tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exceptions or other event reporting. Ensure various regulatory reporting required are met; Study Sponsor, FDA, IRB etc.
Key Stakeholder Interfacing
• Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable
• Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol, consent and amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable
Leadership and Professionalism
• Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies
• Lead and collaborate with CCCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance and or local policy
• Present regulatory status for disease group portfolio at applicable research meetings
Qualifications
QUALIFICATIONS:
Bachelor's degree (BA, BS) required; Master's or other advanced degree highly preferred. 3+ years of direct regulatory experience required. Must have expert knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical trials and/or research coordination and personnel management required.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Subscribe to job alerts and upload your resume!
*By registering with our site, you agree to our
Terms and Privacy Policy.