Clinical Research Coordinator A
About The Position
Responsible for implementing clinical research activities within the Cardiovascular Division with locations at HUP and PPMC. Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research directors, and other research staff. Major duties include screen/enroll patients, conduct follow-up assessments, data collection and use of EDC systems, and assessment of adverse events. This coordinator will assist in ensuring patient and data safety, manage samples and related processing, and will be a proactive communicator with the team and its PIs. Organize and coordinate study procedures, schedule study visits within protocol designated time frames, assure research orders are properly entered into the electronic medical record. Follow-up telephone calls/interview, conduct study visits, including administering questionnaires, escorting patients to protocol-required tests and procedures. Create Smart phrases in EPIC/Penn Chart. This position is contingent upon favorable funding.
Requirements
- Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
Responsibilities
- Assist in coordinating the conduct of assigned clinical trials performed by the physicians of Penn Cardiology and collaborate with principal investigators to assure research activities are conducted with the currently approved protocol/amendments, according to Good Clinical Practice (GCP) guidelines applicable to federal and state requirements and University policies.
- Identify and recruit study subjects - screen regularly to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff, and by reviewing medical data.
- Recruit patients and explain protocol and consent forms. Assure original signed consent forms are maintained in the study binder.
- Creates and maintains research data, regulatory files, subject data and patient tracking databases.
- Assures reported trial data are accurate, complete and verifiable from source documents; collects data on adverse events and reports serious adverse events according to regulatory requirements.
- Organize and coordinate study procedures – schedule study visits within protocol designated time frames; assure research orders and billing information are properly entered into the electronic medical record; ensure protocol dictated patient remuneration.
- Assist in conducting initiation, monitoring and closeout visits with sponsors.
- Provides training and education for patient care staff in all aspects of trial initiation, conduct and closure.
- Serves as primary contact for subjects, sponsors and staff of research related University offices and hospital departments in nursing, pharmacy, billing, medical records related to assign studies.
- Provides oversight of administration of medications, study drugs or study interventions and monitor subject care and status throughout the course of the study.
- Sample processing – process, label, and store human subject blood samples according to study protocol.
- Help manage inventory.
- Assist interventionalists in investigational device trials, device dispensing/accountability.
- Create Smart phrases in EPIC/Penn Chart.
- Other duties and responsibilities as assigned
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts for health care and dependent care expenses
- Tuition assistance for employee, spouse, and dependent children
- Generous retirement plans (Basic, Matching, and Supplemental)
- Substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to a wide range of University resources, cultural and recreational activities
- Discounts on arts and entertainment, transportation, and mortgages
- Flexible work options
- Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
