Biosafety & IBC Compliance Specialist

WCG Clinical, Inc.; United States; Remote; USD 59,000 - 92,000; Full time

Job summary

WCG Clinical, Inc. is seeking a Biosafety Analyst to perform scientific review and analysis for hospitals, clinics, and laboratories to secure Institutional Biosafety Committee (IBC) approvals for human gene transfer studies and related lab work.

You will work with IBC Specialists to prepare documents, educate institutions on NIH Guidelines, ensure regulatory compliance, and coordinate IBC meetings and follow-up actions, with occasional travel (0–5%).

Qualifications

• Bachelor's degree in life sciences or a related field. Advanced degrees a plus.
• At least 2 years’ experience in a clinical, pharmaceutical, or biomedical research setting.
• A combination of education and experience that provides, at minimum, a basic understanding of biomedical terminology, human disease, microbiology and bloodborne pathogens, and clinical safety measures.

Responsibilities

• Analyze the training, facilities, and operations of institutions, and provide guidance to personnel and staff members at these institutions to prepare for IBC review of human gene transfer clinical studies and/or laboratory research projects.
• Provide education and analysis to institutions regarding compliance with the NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acids Molecules and affiliated regulations.
• Assist institutions with identifying areas in their overall biosafety programs that may require improvement in order to comply with regulations and standards.
• Ensure all assigned studies are reviewed by the IBC prior to approval expiration
• Identify training opportunities for new clients and participate in teleconference-based orientations and training for new clients on IBCs, the NIH Guidelines, and WCG IBCS processes and workflows.
• Contribute to continuous improvement initiatives inside the IBC group
• Host teleconference-based convened IBC meetings, record meeting minutes, and assist institutions in addressing specific recommendations and conditions of approval made by the IBC.
• Attendance and punctuality are essential functions of the position.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

Job description

WCG Clinical, Inc. is seeking a Biosafety Analyst to perform scientific review and analysis for hospitals, clinics, and laboratories to secure Institutional Biosafety Committee (IBC) approvals for human gene transfer studies and related lab work.

You will work with IBC Specialists to prepare documents, educate institutions on NIH Guidelines, ensure regulatory compliance, and coordinate IBC meetings and follow-up actions, with occasional travel (0–5%).