Biorepository Research Coordinator II
MedStar Health · Rosedale, MD · 2 days ago
On-siteAnalyst$62k/yrFull-time
About The Job
A Brief Overview
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 Good Clinical Practices (GCP) provided by the International Conference on Harmonization (ICH).
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)