Clinical Research Coordinator C

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

6d•Onsite

About The Position

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.

Requirements

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
practical experience coordinating the day-to-day activities of multiple therapeutic research protocols
effective verbal and written communication skills
ability to learn new methods quickly and multi-task
demonstrated ability to work as part of a team as well as independently
ability to work flexible hours
possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.

Responsibilities

Coordinate the conduct of Phase I – IV clinical trials.
Participate in the conduct of audits by study sponsors, Clinical Research Organizations (CROs), the FDA, and other entities as required.
Activate participation in the development of investigator-initiated protocol case report forms and progress notes
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Organize and maintain all documentation required by sponsor or CRO (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.
Process and ship blood, urine and serum specimens for each trial
Schedule patient visits and any necessary testing
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.
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Utilization of the EMR to research tracking and optimization.
Ability to start up and support multi stie trials
Ability to operationalize a clinical research protocol and build synergistic partnerships to execute
Participate in CRF testing and possibly 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.
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.

Benefits

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
Health, Life, and Flexible Spending Accounts
Tuition assistance for employee, spouse, and dependent children
Generous retirement plans
Time Away from Work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development
Access to a wide range of University resources as well as cultural and recreational activities
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance