Clinical Research Coordinator II- Precision Medicine
St. Luke's University Health Network•Allentown, PA
•Onsite
About The Position
The Clinical Research Coordinator II is responsible for the screening, enrollment, consenting, and coordination of clinical trials ensuring compliance with the protocol and all local, state, ICH/GCP Guidelines, and Federal regulations.
Requirements
- Bachelor’s degree with 3+ years of direct clinical research coordinator experience required
- Knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions
- Must be willing and able to draw and process blood specimens with current phlebotomy training or completion of phlebotomy training within 2 months of hire
Nice To Haves
- Clinical Research certification (e.g. SoCRA, ACRP, etc.) highly preferred
Responsibilities
- Demonstrates knowledge and practice of ICH/GCP guidelines, HIPPA Regulations and Confidentiality Policies related to clinical research
- Sound conduct of the clinical trial, including but not limited to, recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements. This includes performing required study procedures as applicable
- Apply knowledge and skills to independently review new protocols, consents, and other clinical trials documents to ensure protocol compliance
- Review and extract data from medical charts to screen patients for eligibility for assigned protocols
- Review consent form, protocol procedures, and treatment regimen with potential patients and obtain consent from interested participants, documenting the consent process as required
- Maintenance of accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, subjects logs and study-related communication
- Organizational management of all aspects of the trial including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug events, managing caseload and managing study files
- Obtain data from other departments (radiology, pathology, etc.) as required by each protocol
- Prepare research charts for monitoring visits and audits
- Respond to data queries and collate data as requested by research group or investigator, and maintain quality source documentation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
