Clinical Research Coordinator II - Biospecimen

Position 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.
• Congnates 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.
• Aid regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews.
• Aid/coordinate preparation for internal and external audits.
• Provides inventory management of research laboratory supplies.

Qualifications

• Education: Bachelor’s degree (in Nursing, Pharmacy, or Healthcare related).
• Experience: Minimum of 2 years of relevant clinical research experience.
• Familiarity: With basic laboratory principles and safe handling of blood and other biological specimens.

Knowledge, Skills And Ability Requirements

• 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.
• Experience: in preparing and completing Case Report Forms (CRF’s), eligibility checklist and other relevant clinical research documentation.
• Interpersonal skills: Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated team.
• Travel: Ability to travel between clinical sites in the Greater Hartford area, whenever required.