Regulatory Specialist - Oncology Clinical ResearchOdell Medical Search • Teaneck, NJ, US
Regulatory Specialist - Oncology Clinical Research
Odell Medical Search • Teaneck, NJ, US
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job_description.job_card.job_descriptionBA / 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. Certified Clinical Research Professional / CCRP Certified Clinical Research Coordinator / CCRC Certified Clinical Research Associate / CCRA
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 :
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Clinical Research Specialist • Teaneck, NJ, US
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