Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Morristown, NJ 07960
About the Job
Responsibilities
- Assists with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Assists in protocol writing, obtaining the required institutional approvals, and all phases of the protocol lifecycle to ensure that protocol amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
- Assists with collecting and monitoring required research training certifications and other study personnel documents for MCCRP investigators and study team.
- Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures (SOP), GCP and applicable regulatory.
- Performs tasks associated with the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; tracks MCCRP scientific publications and provides regular reports to institutional.
- May perform other duties and responsibilities as assigned or directed by the supervisor.
- This may include attendance of and participation in required training for role.
- Bachelor's Degree is required.
- Minimum of 5 years of experience required.
- Basic knowledge of human subjects' research regulations.
- Must have experience working on regulatory items for research protocols.
- Excellent writing skills (able to clearly and concisely explain scientific and technical ideas in simple language). Attention to detail.
- Strong organizational skills and strong time management skills.
- Excellent communication and interpersonal skills (able to interact and communicate effectively with experts in medical, academic, research, technical, military, and administrative fields).
- Oncology experience is a plus.
- Proficiency with computer applications such as MS Word, Excel, PowerPoint, and Adobe.
Source : Katalyst Healthcares & Life Sciences
