Clinical Research Coordinator II - Biospecimen
Hartford Healthcare•Hartford, CT
•Hybrid
About The Position
The Clinical Research Coordinator II of Cancer Clinical Research Office (CCRO) is an integral member of the research team. In compliance with all regulatory, institutional and departmental requirements performs patient screening, consent, data collection and data entry for research protocols, and projects within Hartford Healthcare Cancer Institute. This position specifically supports studies that involve collection of biospecimens such as blood and leftover surgical tissue.
Requirements
- Bachelor’s degree (in Nursing, Pharmacy, or Healthcare related).
- Minimum of 2 years of relevant clinical research experience.
- Familiar with basic laboratory principles and safe handling of blood and other biological specimens.
- Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection.
- Review patient medical charts – familiar with Epic or other electronic medical record
- Phlebotomy trained or willing to train.
- Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: RedCap, Medidata, RAVE, etc.) and querying.
- Experience in preparing and completing Case Report Forms (CRF’s), eligibility checklist and other relevant clinical research documentation.
- Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated team.
- Ability to travel between clinical sites in the Greater Hartford area, whenever required.
Responsibilities
- Coordinate and facilitate the appropriate conduct of biospecimen studies in oncology: screening and consenting patients, collecting blood and other specimens from study patients.
- Works with clinical trial coordinators on research specimen collection, processing, shipping and timed assessments.
- Coordinates with pathology and study sponsors for submission of archived surgical tissue samples.
- Reviews cancer clinical trial protocols and laboratory manuals for logistical planning and training needs.
- Conduct studies in accordance with federal regulation and guidelines governing clinical research including informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring; processing, storing and shipping of research specimens in accordance with study laboratory manual and IATA regulations.
- Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelines.
- Prepare study calendars and materials; maintain participant tracking logs and screening/enrollment logs.
- Performs research blood draws as needed.
- Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews.
- Assist research account specialist of CCRO with clinical trial billing in the resolution of related queries.
- Assist/coordinate preparation for internal and external audits.
- Provides inventory management of research laboratory supplies.
Benefits
- competitive benefits program designed to ensure work/life balance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
