- Title: Biospecimen Specialist
- Code: RCI-CELG-8282
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 08/12/2019
- Duration: 6 Months
- Name:Divya Bhatt
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 221
Qualifications: Bachelors Degree in a life sciences or healthcare related field with 6+ year’s related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
The Biospecimen Operations (BSO) group focuses on management of biospecimens for Celgene sponsored clinical trials. The Consent Specialist will focus on patient informed consent and the management of consent parameters that govern the retention period, use and re-use of biospecimens collected during the course of a clinical trial.
This role will support the BSO Executive Director as a subject-matter expert in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations. The Consent Specialist will be expected to optimize processes around interpreting and documenting clinical trial biospecimen consent parameters from study, country and site-specific consent templates for a specific study and upload these parameters into a technology tool.
The Consent Specialist will act as a mentor to peers and is expected to assist them with consent related IRB/EC queries as well as provide training to help develop a group of consent experts within BSO.
The Consent Specialist in BSO is expected to review consent documents and interpret consent allowable uses and retention periods in order to maintain adherence to the collection, retention and utilization of biospecimens in line with the informed consent signed by the subject. In doing so, the incumbent is expected to stay current on the broader regulatory landscape related to biospecimens.
- Apply subject matter expertise to the review of informed consent documents, including study, regional, country, and site-level documents, and summarize information regarding use and retention
- Guide CROs and clinical teams on the proper use of protocol and informed consent template materials for the collection and use of biospecimens in Celgene clinical studies
- Provide support for resolving IRB/IEC queries related to biospecimens for Celgene clinical studies
- Assist with the development and updating of policies, standard operating procedures (SOPs) and working procedures (WPs) related to consent oversight. Be able to identify complex biospecimen-related consent permissions. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
- Utilize software tools to track consent parameters, verify and document consent prior to release for utilization, and ensure compliant utilization of biospecimens by following written procedures
The incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen management.
- Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
- Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
- Informed Consent: Subject-matter expertise in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations
- Drug Development: Proficient understanding of the drug development process.
- Professional inter-personal skills and excellent oral/written communication. Experienced in presenting to internal and external audiences.
- Basic leadership skills in conflict management, facilitation and negotiation.
- Proficient computer skills in Microsoft Office.
- Experience with consent tracking databases preferred.
Up to 10% travel to conferences to stay up to date on global regulations on biospecimens. The travel is not known at this time but may be required. It could include international travel given one of the legal groups the manager works with extensively is in Switzerland but more likely will be in the US.