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.
JOB DUTIES AND 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
PHYSICIAL AND SENSORY REQUIREMENTS:
Requires sitting for up to seven hours per day, 4 hours at a time. Standing for up to 4 hours per day, 3 hours at time. Requires frequent fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 25 pounds. Occasionally requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
EDUCATION:
Bachelor’s degree with 3+ years of direct clinical research coordinator experience required. Clinical Research certification (e.g. SoCRA, ACRP, etc.) highly preferred.
TRAINING AND 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.
Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!
Founded in 1872, St. Luke’s University Health Network (SLUHN) is a fully integrated, regional, non-profit network of more than 23,000 employees providing services at 16 campuses and 350+ outpatient sites. With annual net revenue of $4 billion, the Network’s service area includes 11 counties in two states: Lehigh, Northampton, Berks, Bucks, Carbon, Montgomery, Monroe, Schuylkill and Luzerne counties in Pennsylvania and Warren and Hunterdon counties in New Jersey. St. Luke’s hospitals operate the largest network of trauma centers in Pennsylvania, with the Bethlehem Campus being home to St. Luke’s Children’s Hospital. Dedicated to advancing medical education, St. Luke’s is the preeminent teaching hospital in central-eastern Pennsylvania. In partnership with Temple University, the Network established the Lehigh Valley’s first and only four-year medical school campus. It also operates the nation’s longest continuously operating School of Nursing, established in 1884, and over 50 fully accredited graduate medical educational programs with more than 500 residents and fellows. In 2022, St. Luke’s, a member of the Children’s Hospital Association, opened the Lehigh Valley’s first and only free-standing facility dedicated entirely to kids. SLUHN is the only Lehigh Valley-based health care system to earn Medicare’s five-star ratings (the highest) for quality, efficiency and patient satisfaction. It is both a Leapfrog Group and Healthgrades Top Hospital and a Newsweek World’s Best Hospital. The Network’s flagship University Hospital has earned the 100 Top Major Teaching Hospital designation from Premier 13 times total and eleven years in a row, including in 2023 when it was identified as THE #4 TEACHING HOSPITAL IN THE COUNTRY.
