"Clinical Research Coordinator B (Department of Gastroenterology)"

Clinical Research Coordinator B (Department of Gastroenterology)

University Overview

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The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Research Coordinator B (Department of Gastroenterology)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

The Division of Gastroenterology Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement different phases of investigator-initiated and industry-sponsored clinical trials of novel therapies or currently available therapies, as well as prospective and retrospective observational studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.

The Clinical Research Coordinator (CRC) is an integral and essential member of the Research Team. We are looking for an enthusiastic, professional and committed team member who will help accelerate our program through the conduct of cutting-edge clinical trials.

Job Description

Job Responsibilities:

• Coordinate Phase I - IV clinical trials.
• Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., source documentation, case report forms, study and regulatory binders, and patient binders).
• Resolve data queries with sponsor and CROs
• Recruit, screen and enroll potential study patients as specified per protocol.
• Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.
• Process and ship blood, urine, and serum specimens for each trial.
• Schedule patient visits and any necessary testing; within the EMR or other tools
• Attend Investigator Initiation meetings
• Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
• Obtain records required to complete case report forms.
• Maintain source documentation
• Ability to communicate and build a rapport with subjects
• Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs.
• Show vigilance in patient safety, protocol compliance, and data quality.
• Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
• Coordination and oversight on time to study start up
• Provide feedback and critical analysis of clinical research protocols
• Participate in CRF testing and potentially design
• Other duties and responsibilities as assigned

Regulatory Responsibilities:

• Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
• Prepare and process all regulatory documentation with pharmaceutical companies and CROs.
• Obtain the appropriate signatures for regulatory forms.
• Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators' CVs and medical licenses, record of IRB certification and compliance).
• Resolve regulatory related queries with IRB, study sponsors and CROs.

Qualifications

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

This position is contingent upon grant funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $56,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.