Regulatory Specialist - Oncology Clinical Research
- 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
- 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
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