Regulatory Specialist - Oncology Clinical Research

Odell Medical Search

  • Teaneck, NJ
  • Permanent
  • Full-time
  • 1 month ago
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:
  • 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
  • Strong attention to detail and customer service focus.
  • Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.
  • Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.
Licenses and Certifications Preferred:
  • Certified Clinical Research Professional/CCRP
  • Certified Clinical Research Coordinator/CCRC
  • Certified Clinical Research Associate/CCRA

Odell Medical Search