Clinical Research Coordinator C

University of Pennsylvania Perelman School of Medicine

1d•Onsite

About The Position

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner. Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. They will provide bi-weekly updates to the research team and the PI. This role requires a combination of both comprehensive clinical research coordination including ophthalmic clinical diagnostic testing. The position reports to the project PIs.

Requirements

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
prior experienced required

Nice To Haves

ophthalmic clinical diagnostic testing

Responsibilities

Coordinate Phase I-IV clinical trials (prior experienced required)
Recruit, consent, and screen patients according to protocol
Schedule patient visits and any necessary testing. Monitor patients per protocol requirements and ensure adherence to protocol requirements
Organize and maintain all required documentation- including source documentation, case report forms, and research charts. Collect, review and report study data, Complete case report forms and resolve data queries
Process and ship study specimens including blood, urine and tissue samples
Participate in the initiation, monitoring, audit, and close-out visits.
Participate in study team meetings site group meetings, and ongoing protocol training/compliance meetings
Assist Project Managers with study start-up for new clinical trials including working with OCR Finance and Legal with completion of CTA and Budget
Develop/maintain study specific case report forms and source document tools
Participate in the coordination of Phase I-IV clinical trials (10% Essential: 1) Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other applicable review
Assist Project Managers in training new staff
Other duties and responsibilities as assigned

Benefits

excellent healthcare
tuition benefits for employees and their families
generous retirement benefits
wide variety of professional development opportunities
supportive work and family benefits
wealth of health and wellness programs and resources
Health, Life, and Flexible Spending Accounts
comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
exceptional tuition benefits
tuition assistance here at Penn
tuition assistance at other institutions for dependent children
generous retirement plans
Penn’s Basic, Matching, and Supplemental retirement plans
save for retirement on a pre-tax or Roth basis
wide variety of investment options through TIAA and Vanguard
substantial amount of 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