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:

• 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