Under moderate supervision in a fast-moving team-based environment, the Specialist will provide biospecimen and clinical trial support across multiple studies, execute on biospecimen operations logistics and provide biospecimen processing training. As part of BSO, the specialist will gain exposure to the planning of clinical trial and biospecimen operations across a variety of platforms. The ideal candidate is a team-player who is detail-oriented; can successfully multi-task, supporting several projects simultaneously; understands the broader context and impact of the support that he/she provides; knows how to identify/recognize issues and propose solutions with moderate guidance.
Responsibilities will include, but are not limited to, the following:
The Specialist will be expected to be an active participant of the internal work group and will often be expected to go beyond assigned tasks that support the department’s mission. The primary responsibilities of the BSO Specialist are to support TD and clinical teams in the implementation and maintenance of a biospecimen management system for global clinical studies in each of the following areas under moderate supervision:
- BSO: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Assist manager with various delegated responsibilities that pertain to clinical trial and biomarker operations support.
- Biospecimen management: Utilize software tools such as Labmatrix to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
- Clinical study teams: Under direction of supervisor, work with clinical development teams to help plan/design biospecimen handling logistics and review biomarker-related clinical documents for successful study start-up i.e. clinical protocols, ICFs, CRFs. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Work with clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented chain-of-custody and rapid reconciliation of biospecimens.
- CROs and Vendors: Under direction of supervisor, assist clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; work with manager and scientists with analytical laboratories on work order requests and logistics pertaining to biospecimen deployment.
Demonstrated knowledge and mastery of basic skills are required in each of the following areas:
- Clinical Trials: Basic knowledge and awareness of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
- Scientific/Laboratory Skills: Basic knowledge of relevant therapeutic and technical areas; demonstrated understanding of basic laboratory techniques in the life sciences; demonstrated understanding of basic principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing.
- Bio-banking: Awareness of global biobanking issues; basic experience in working in organizations adhering to quality standards and procedures; awareness of regulations pertaining to general biospecimen transportation requirements.
- Drug Development: Basic understanding of the drug development process.
- Professional inter-personal skills and excellent oral/written communication. Must be comfortable presenting in front of internal and external audiences.
- Leadership skills in conflict management, facilitation and negotiation a plus.
- Basic computer skills in Microsoft Office.
- Experience with databases and intermediate-level Excel a plus.
- Up to 15% travel to clinical sites to train sites on biospecimen procedures
- Bachelor’s Degree in a life sciences or healthcare related field with 4+ year’s related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR Master’s Degree in a life sciences or healthcare related field and 3+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment