Consent Specialist, Biospecimen Operations
Newark Metro Area, NJ
The Biospecimen Operations (BSO) group focuses on management of biospecimens for our 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 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.