Under minimal supervision of the Biorepository Clinical Program Manager, the Biorepository Research Coordinator II is dedicated to acquisition, delivery, and processing of human biological samples for research. Performs diverse administrative duties requiring analysis, sound judgment, and a high-level knowledge of daily operations.
What you will do- Pre-screens potential research participants to determine their initial eligibility and interest in specimen collection(s). Adheres to important guidelines to protect the privacy of the patients. Screens, recruits, and enrolls research participants.
- Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks, benefits) and obtain all required signatures. Ensures the research participant has sufficient time and opportunity to ask the investigator medical questions. Documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.
- Maintains study source documents (e.g., surgical and pathology reports, medical history); accurately completes and maintains case report forms Addresses all queries and clarification. Documents written and verbal communication with study contacts (e.g., research participant, sponsor, pathology). Completes and submits case report forms within established timelines.
- Ensures proper collection, processing, and shipment of biospecimens (e.g., centrifuge, freezing, refrigeration). Maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens. Maintains International Air and Transportation Association (IATA) training for routine packaging, labeling, and transporting of biological materials.
- Biospecimen Acquisition, Delivery, and Processing: Works closely with surgical team and surgical pathology to obtain biospecimens from consented donors as required by the protocol. Communicates with Biorepository Clinical Program Manager(s) to ensure that biospecimens meet the collection criteria and ensures specimens are handled according to best practices and policies and procedures. Reviews surgery schedules and identifies potential donors for biospecimen collection. Reviews patient's health record to ensure that the donors meet inclusion criteria for collection based on the protocol.
- Clinical Annotation of Biospecimen: Understands electronic health record and extractis data and mentors junior members. Reviews MedStar Health's electronic health record to confirm data accuracy and abstract outcomes; works with team across many sites nationally and internationally to ensure all data is coded correctly for global database, updates database regularly; registers tissue samples and associated data in MedStar Health, sponsor, and other (e.g., Georgetown University) databases; regularly performs quality assurance and control checks.
- Handles hazardous materials to maintain proper temperature during shipping such as gel packs, dry ice, and liquid nitrogen.
- Works closely with Biorepository Clinical Program Manager and acts as a liaison with research participants, investigators, sponsors, and healthcare professionals. Ensures all research participant encounters are updated as appropriate and within one business day in the clinical trial management system (CTMS). Works effectively with multidisciplinary, ancillary, and inter-professional research team. Possesses a basic understanding of scientific center goals and the importance of serving customers.
Qualifications- Bachelor's degree Required
- 2 years of progressively more responsible job related experience in research Required
- Strong communication and organizational skills.
- Proficient computer software and database skills. (Medium proficiency)
- The ability to work independently as well as part of a team
- Understanding written sentences and paragraphs in work related documents.
- Must possess basic understanding of Good Clinical Practices (GCP) provided by the International Conference on Harmonization (ICH).
This position has a hiring range of USD $62,254.00 - USD $101,836.00 /Yr.
