Remote Biosafety & IBC Compliance Analyst

WCG Clinical, Inc.; Montpelier (VT); Remote; USD 59,000 - 92,000; Full time

Job summary

The Biosafety Analyst at WCG provides scientific review and analysis for institutions such as hospitals, clinics, and laboratories so that studies and projects can be reviewed and approved by an Institutional Biosafety Committee (IBC). Areas of research include human gene transfer clinical trials and related laboratory work.

Responsibilities include preparing documents for IBC review, educating institutions on NIH Guidelines, coordinating training for new clients, and contributing to continuous

Qualifications

• At least 2 years of experience in a clinical, pharmaceutical, or biomedical research setting.
• 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 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 biosafety programs that may require improvement 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.

Education

Bachelor's degree in life sciences or related field

Advanced degrees a plus

Job description

The Biosafety Analyst at WCG provides scientific review and analysis for institutions such as hospitals, clinics, and laboratories so that studies and projects can be reviewed and approved by an Institutional Biosafety Committee (IBC). Areas of research include human gene transfer clinical trials and related laboratory work.

Responsibilities include preparing documents for IBC review, educating institutions on NIH Guidelines, coordinating training for new clients, and contributing to continuous