Clinical Research Coordinator B

Clinical Research Coordinator BUniversity Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.

As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities.

With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. 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.

Clinical Research Coordinator B

Clinical Research Coordinator B

The clinical research coordinator B will manage the coordination of Phase I-IV multi-center clinical trials, including coordination, organization and maintenance of all documentation required by Sponsor or CRO as well as working with partnering institutions on managing invoicing, and IRB paperwork under limited supervision and will need to use independent judgment; resolve data queries with Sponsor or CRO; recruit, screen and enroll potential study subjects;

participate in the conduct of audits; process and ship blood and specimens; schedule patient visits and any necessary testing; obtain records required to complete case report forms; conduct initiation, monitoring and close out visits with Sponsor of CRO; adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B will also manage clinical trials that involve hands-on, technologically advanced and special skill set involving investigational procedures with Radiology.

Clinical Research 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.
• Participant/ subject appreciation and recognition.
• 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.

• 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…