Senior Regulatory Compliance Coordinator
New
J
JobgetherClinical Research
Based in the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- Project Management
Requirements
- Demonstrated experience in clinical research, regulatory affairs, clinical trial coordination, or a closely related field.
- Strong understanding of the regulatory requirements and processes associated with clinical research and cancer clinical trials.
- Experience preparing, reviewing, and submitting documentation for IRB review and other regulatory or safety reporting requirements.
- Ability to manage clinical studies through regulatory submission, approval, maintenance, amendment, and closure activities.
- Experience working with investigators and multidisciplinary research teams in a clinical or academic research environment.
- Strong organizational and project coordination skills, with the ability to manage multiple studies, deadlines, submissions, and priorities simultaneously.
- Excellent written and verbal communication skills, with the ability to correspond effectively with investigators, committees, sponsors, agencies, and research personnel.
- Strong attention to detail and commitment to maintaining accurate, complete, and compliant regulatory documentation.
- Demonstrated ability to mentor, train, and provide guidance to junior staff and study teams.
Responsibilities
- Manage the regulatory components of assigned cancer clinical trials throughout the submission and study lifecycle, from initial approval through study closure.
- Ensure the regulatory integrity, completeness, and accuracy of assigned clinical trial documentation and submissions.
- Work closely with investigators and research teams to develop new clinical trials and support protocols during the development and start-up phases.
- Serve as a primary regulatory contact during protocol development, coordinating communications and documentation with reviewing committees and relevant personnel.
- Coordinate and prepare materials required for Institutional Review Board (IRB) submissions and reviews.
- Support the preparation and submission of regulatory and safety documentation to sponsors, regulatory bodies, and other applicable agencies.
- Mentor junior regulatory staff and provide oversight and training to study teams.
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