Newark Metro Area, NJ
Bachelor s Degree in a life sciences or healthcare related field with 4+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR Masters 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
Under moderate supervision in a fast-moving team-based environment, the Specialist I 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.
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.
Biobanking: 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.