Specialist

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• Job Title: Specialist
• Department: Bio-Repository
• Full/Part Time: Full
• Req Number: UHS-30782

• Coordinates biorepository clinical research studies in adherence to the research protocol and in compliance with FDA regulations and Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

• Coordinates IRB submissions and regulatory documentation for biorepository research studies.

• Responsible for the identification and consent of eligible patients.

• Screens EMRs to identify potentially eligible patients.

• Works with clinical staff to coordinate patient interactions.

• Interacts with patients to obtain consent and clinical data acquisition.

• Reviews EMR and perioperative reports to complete clinical data abstraction.

• Receives resected tumor/tissue from surgeon/care provider and responsible for timely transport of tissue to pathology. Works closely with pathology team to obtain all excess tissue available for research and plans.

• Plans and performs dissection of tissue specimen according to standard operating procedures.

• Processes tissue for storage and distribution to partner sites, collaborators and sponsor.

• Enters specimen collection and associated patient data into Biorepository Inventory System.

• Extracts relevant data from EMR to fill out researchers/client Case Reports Forms or external systems.

• Works with researchers to manage and update study status of collected biospecimens.

• Assists in coordinating and overseeing daily Biorepository activities.

• Regularly performs quality assurance and control checks.

• Ensures trainings and certifications are up to date, including but not limited to all CITI (HIPAA and Human Subjects), IATA/DOT certifications, and all safety trainings.

• Supports various prospective tissue collections, tissue shipments, and tissue/data release requests.

• Phlebotomy and blood processing according to project requirements.

• Other duties and projects as assigned.

Education:

• Bachelor's Degree in scientific field.

Experience:

• 3 years of work experience in clinical or research setting.

• Experience working in/with a Biobank preferred.

• Experience with IRB submissions and regulatory documents for clinical research studies preferred.

• Phlebotomy or training in phlebotomy to be completed within six (6) months of hire.