Clinical Research Coordinator C (Cancer Center)
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Posted Job Title
Clinical Research Coordinator C (Cancer Center)
Job Profile Title
Clinical Research Coordinator C
Job Description Summary
The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (“Program”) of the University of Pennsylvania seeks a full-time Clinical Trials Coordinator C. This position will (1) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator, study team and Sponsor/CRO.
This individual will work independently under minimal supervision. May act in a lead capacity or as back-up to the Supervisor, which includes oversight of the study team and serving as the point-of-contact for day-to-day situations:
- Plan, organize, and run study-related meetings, including but not limited to Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits and ongoing training sessions.
- Take a lead role in Site Feasibility and Qualification Visits; work in conjunction with the Unit Managers to initiate start-up processes for industry-sponsored and Investigator-initiated trials; independently manage the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials inclusive of managing multi-site projects where Penn is the lead site.
- Prepare components of submissions to the IRB (and other entities) and remain aware of the regulatory statuses for assigned protocols; may be asked to draft or edit study protocols and associated documents (e.g., informed consent, manuals of procedures, etc.).
- Responsible, in conjunction with the study team, for ensuring successful patient recruitment and enrollment goals are met within specified timelines; develop study brochures and coordinate outreach to clinics and private providers; triage interest inquiries and prescreen potential patients.
- Conduct informed consent process (i.e., non-interventional studies), contribute to informed consent discussion (i.e., interventional studies) and ensure appropriate documentation of consent; facilitate eligibility review; develop, schedule, and oversee subject visits in conjunction with the Study Team; show vigilance in patient safety, protocol compliance and data quality; adhere to all University of Pennsylvania, FDA and GCP guidelines.
- Collect, prepare, ship and/or store biological materials using universal precautions; facilitate independent review of tissue and imaging; receive and maintain central lab supplies, kits, and equipment provided by the Sponsor; assist with billing reconciliation, tracking site reimbursements and allocating patient stipends.
- Maintain complete, accurate, and well-organized study files from patient screening through final follow-up; keep files in an up-to-date and audit-ready state; participate in the development of study-specific Case Report Forms and other data collection tools.
- Collect, review and report timely, valid, accurate study data within the timelines specified by the study Agreement; document and report (i.e., to regulatory/governing bodies) AEs, SAEs, and EOIs; maintain up-to-date list of incidental deviations; draft or edit information for reportable deviations, unexpected events and exception requests; coordinate IND safety reporting; contribute to study reports, abstracts, posters, manuscripts, and grant application.
- Participate in Sponsor teleconferences, Program meetings, and working groups that will maximize the efficiency and quality of research performed, including developing SOPs; may be responsible for orientation/training of new staff and act as a resource to current staff members with study-related issues; provide coverage and support to other Coordinators to meet departmental/organizational staffing needs.
- Assist the Unit Managers with QA processes related to research studies; take a lead role in preparing for any inspection (e.g. internal and external audits) that takes place with the trials, as required.
Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding.
Bachelor's degree and 3-5 years of experience or equivalent combination of education and experience required.Job Location - City, State
Philadelphia, PennsylvaniaDepartment / School
Perelman School of MedicinePay Range
$51,824.00 - $78,096.00Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University Benefits
Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Coordinator-C--Cancer-Center-_JR00051688
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