Oncology Clinical Research Coordinator II
About The Position
Work where every moment matters. Every day, over 40,000 Hartford HealthCare colleagues come to work with one thing in common\: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut’s most comprehensive healthcare network. The Clinical Research Coordinator ll of Cancer Clinical Research Office (CCRO) is an integral member of the research team. This position will support a portfolio of cancer research studies. In compliance with all regulatory, institutional and departmental requirements, performs patient screening, data collection and data entry for research protocols, databases and projects within Hartford Healthcare Cancer Institute, and ensures the data quality and integrity for each clinical trial.
Requirements
- Bachelor’s degree (in Nursing, Pharmacy, or Healthcare related).
- Minimum of 2-3 years of relevant clinical research experience.
- Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection.
- Ability to work with spreadsheets (such as Excel), familiarity with databases (ex\: Medidata, RAVE, IRIS, NSABP, GOG, RTOG etc.) and querying.
- Experience with Microsoft Access, Excel and electronic data capture systems.
- Experience in preparing and completing Case Report Forms (CRF’s), eligibility checklist and other relevant documentation protocols.
- 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, whenever required. This includes travel to Hartford for required training and on-boarding.
Responsibilities
- Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI, industry, cooperative groups or HHC system alliances.
- Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.
- Interact/collaborate with all physicians, other members of the health care team and participants/families across the system in a manner that supports the conduct of clinical trials.
- Required to attend the respective system-wide Disease Management Team meetings and present the clinical trials to potential investigators.
- Collaborate with and support other clinical trial staff across the system to ensure highest quality clinical research activities.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
