Remote Biosafety & IBC Compliance Analyst

WCG Clinical, Inc.; Dover (DE); À distance; USD 59 000 - 92 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with company match

Tuition reimbursement

On-the-job training

Continuing education support

Résumé du poste

WCG is seeking a Biosafety Analyst to provide scientific review and analysis for institutions such as hospitals, clinics, and laboratories to support institutional biosafety committee (IBC) review and approval of studies. This role involves evaluating biosafety practices for human gene transfer trials and related laboratory work, and coordinating with IBC Specialists on documentation and processes.

Responsibilities include preparing IBC review materials, educating institutions on NIH Guidelines,

Qualifications

• At least 2 years’ experience in a clinical, pharmaceutical, or biomedical research setting.
• A combination of education and experience that provides a basic understanding of biomedical terminology, human disease, microbiology and bloodborne pathogens, and clinical safety measures.

Responsabilités

• Analyze the training, facilities, and operations of 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.

Connaissances

Clinical research

Biomedical terminology

Attention to detail

Formation

Bachelor's degree in life sciences

Description du poste

WCG is seeking a Biosafety Analyst to provide scientific review and analysis for institutions such as hospitals, clinics, and laboratories to support institutional biosafety committee (IBC) review and approval of studies. This role involves evaluating biosafety practices for human gene transfer trials and related laboratory work, and coordinating with IBC Specialists on documentation and processes.

Responsibilities include preparing IBC review materials, educating institutions on NIH Guidelines,