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Clinical Research Coordinator I- Precision Medicine
Job detail
Clinical Research Coordinator I- Precision Medicine
The coordinator is responsible for the screening, enrollment, and coordination of clinical trials while ensuring compliance with protocol and federal regulations. Key duties include managing study documentation, performing study procedures, and coordinating data collection across departments.
Requirements summary
A Bachelor's degree and at least 3 years of direct clinical research coordinator experience are required. Candidates must be proficient in Microsoft Office and be able to perform phlebotomy or complete training within two months of hire.
Luke's is proud of the skills, experience and compassion of its employees.
The employees of St.
Luke's are our most valuable asset!
Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.
The Clinical Research Coordinator (CRC) assumes a critical role in the research process.
The CRC 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.
The CRC is also responsible for maintaining quality data for all patients enrolled into clinical trials as assigned, ensuring timely and accurate data entry for trials as assigned.
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.
Review charts for adverse events and submit appropriate documentation Submit follow-up information as specified by protocol.
Long-term survival follow-up may require extensive time acquiring medical records from other physician offices, patient and/or family contact, or correspondence with regulatory agencies.
Supports conduct of clinical trials, including travel to physician offices and national meetings/conferences Communication of all protocol-related issues/problems, and other relevant study information to the appropriate medical and management staff.
Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
Provide direction/training to other members of research staff as appropriate.
For example, guidance to clinical research associate in completing case report forms.
Preparation and shipping of laboratory specimens to study (central) laboratories and maintenance of appropriate certifications related to this function (for example, IATA training).
PHYSICAL AND SENSORY REQUIREMENTS: Requires sitting for up to seven hours per day, 3 hours at a time.
Standing for up to 4 hours per day, 3 hours at time.
Requires occasional fingering, handling and twisting and turning.
Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 25 pounds.
Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
EDUCATION: Bachelor’s degree required; will accept Associates degree or High School degree with equivalent clinical research experience (3 years) with 1-2 years coordinator and/or data management experience highly preferred.
Must be familiar with medical terminology.
TRAINING AND EXPERIENCE: Required knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions.
Experience in health-related field (2 years) required.
One year experience in clinical research highly preferred.
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!!
St.
Luke's University Health Network is an Equal Opportunity Employer.
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 in excess 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.
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.
In 2021, St.
Luke’s was identified as one of the 15 Top Health Systems nationally.
St.
Luke’s is the ONLY health care institution in the Lehigh Valley to be named a Top Workplace regionally repeating the exclusive honor for the third year in a row.
Also, for the third straight year, St.
Luke’s has been a Top Workplaces in the Philadelphia Region by the Philadelphia Inquirer, ranking 9th in the large employer category for 2025 and the only health care system in PA to receive this award.
In 2025, St.
Luke’s was recognized as a national Top Workplaces by USA Today, three years in a row, including the 3rd best health care system in the nation in 2023 and 2024.
Lastly, in 2025, St.
Luke’s was named a Top Workplace in New Jersey for the third year in a row.
Learn More Here.
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