Clinical Research Coordinator A (Department of Cardiovascular Medicine)
University 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.
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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 A (Department of Cardiovascular Medicine)
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
This position requires an Research Coordinator to assist in clinical research tasks in the Cardio-Oncology Clinical Research program. Responsibilities will include screening records for eligibility, recruitment of study subjects, conducting study visits, data collection and entry, coordinating with study team members and external departments to successfully execute studies. In addition, this position will assist with Coordinating Center activities to help manage multi-site clinical trials and assist with regulatory submissions.
Job Description
This position is contingent upon favorable funding.
Job Responsibilities
Recruit patients and explain protocol and consent forms. Assure original signed consents are maintained in study binder, Complete screening/enrollment logs and submit to sponsor, as protocol defines
Assist in the conduct of clinical research studies performed by physicians using currently approved protocols, according to Good Clinical Practice. Obtain detailed knowledge of all components of study protocols by review of study protocol, related literature prior to study start date. Assure accurate and timely completion & updating of the Delegation of Duties and Authorized Signatures Form. Create & maintain research data, regulatory files, subject data, billing records,
Complete all source documents and worksheets and enter data in a timely and accurate fashion. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors in a timely manner. Monitor adherence to protocol throughout patient enrollment in study. Notify PI, project manager of any deviations from protocol or adverse events. Assure reported trial data are accurate, complete, and verifiable from source documents; collect data on adverse events and reports serious adverse events per regulatory standards. Assure correct version of approved consent is used for each enrollment. Assure timely notification to all enrolled subjects of significant changes in consent.
Provide clinical research coordination support to Penn Center for Quantitative Echocardiography, including assisting with data entry, maintaining study records, and communicating with sites/sponsors on studies where we serve as Core Lab.
Create and maintain a complete and accurate regulatory binder for each study. Assist with preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms. Prepare for audits and monitoring visits.
Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures.
Work with project manager and PI to manage external sites on multi-site studies where Penn serves as coordinating center - this will include reviewing the database for accurate and timely data entry, verifying data entry against source documentation; issuing and following up on queries; reviewing site regulatory files for completeness; and contributing to reports on study progress.
Other duties and responsibilities as assigned
Qualifications
Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. Proficient in Microsoft Windows including Microsoft Excel. Candidate must be willing to perform basic processing of human blood samples. Hard working, detail-oriented; and excellent organizational, interpersonal and communication skills required. Familiarity with EPIC, REDCap, and medical terminology preferred.
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$37,220.00 - $44,947.00 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, as well as internal and market factors and grade profile.
Affirmative 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.
