Regulatory Specialist - Oncology Clinical Research

Job Description

Job Description

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

Qualifications :

Licenses and Certifications Preferred :