Regulatory Specialist - Oncology Clinical Research
Med-Hunters
Clinical Research Organization in Northern New Jersey is seeking 2 Oncology Clinical Research Regulatory Specialists to join their oncology clinical research team. Must be able to work onsite at least 2-3 days per week. These positions consist of a hybrid schedule which would be onsite and remote.
- Promoting compliance with Federal Regulations, Good Clinical Practice (GCP) and Institutional policies
- Serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies
- Attends and actively participates in study team meetings, sponsor meetings and research meetings, and conferences/in-service education sessions as required
- Assists in developing procedures to ensure regulatory compliance
- Ensures timeliness and accurate submission of all protocol amendments, ICF, Investigator Brochure and other administrative items to the IRB of record
- BA/BS degree in the science/health care field or communication field or equivalent related education and experience
- Mandatory education on human subject research and GCP
- Knowledge of clinical trials
- Prefer oncology experience but not required
- Certified Clinical Research Professional/CCRP
- Certified Clinical Research Coordinator/CCRC
- Certified Clinical Research Associate/CCRA
Vacancy posted 4 days ago
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