What are the responsibilities and job description for the Senior Regulatory Coordinator - The Angeles Clinic & Research Institute position at Cedars-Sinai?
Job Description
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Join our team and contribute to groundbreaking research.
The Senior Regulatory Coordinator prepares and submits moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role submits the continuations, amendments to regulatory bodies and responds to a broad range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial.
Primary Duties and Responsibilities:
Requirements:
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Join our team and contribute to groundbreaking research.
The Senior Regulatory Coordinator prepares and submits moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role submits the continuations, amendments to regulatory bodies and responds to a broad range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial.
Primary Duties and Responsibilities:
- Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
- Completes forms and generates reports from multiple data sources to comply with the assigned protocols for the study and/or clinical trial.
- Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trials.
- Responds to generally broad data requests and questions.
- Monitors the status of assigned regulatory submissions and amendments from end-to-end.
- Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.
- Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.
- Supports the unit in internal and external auditing of regulatory documents.
- Identifies quality and performance improvement opportunities to support efficient workflows.
- Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.
Requirements:
- Bachelor's Degree required.
- 3 years of experience in clinical research or related field.
- Experience in regulatory affairs and good knowledge of federal and local regulatory requirements is highly preferred.
- Certification in Clinical Research from SOCRA or ACRP is preferred.