Clinical Research Coordinator B/C

University of Pennsylvania•Philadelphia, PA

About The Position

Clinical Research Coordinator B Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Major duties include screen/enroll patients, conduct follow-up assessments, data collection and use of EDC systems, assessment of adverse events. This coordinator will assist in ensuring patient and data safety, manage samples and related processing, and will be a proactive communicator with the team and its PIs. Clinical Research Coordinator C Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC. Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Performs screening visits, consenting of participants, processing and shipping of labs, entering data into databases, escorting participants to other testing/procedure areas.. . Coordinate several investigational device trials in the cath lab, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements. This position is contingent upon favorable funding.

Requirements

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Responsibilities

Assist in coordinating the conduct of assigned clinical trials performed by the physicians of Penn Cardiology and collaborates with principal investigators to assure research activities are conducted with the currently approved protocol/amendments, according to Good Clinical Practice (GCP) guidelines applicable federal and state requirements and University policies.
Provides oversight of administration of medications, study drugs or study interventions and monitor subject care and status throughout the course of the study.
Creates and maintains research data, regulatory files, subject data and patient tracking databases.
Assures reported trial data are accurate, complete and verifiable from source documents; collects data on adverse events and reports serious adverse events according to regulatory requirements.
Prepares all documents for IRB review including draft informed consents written for subject reading levels.
Assist in conducting in conducting initiation, monitoring and closeout visits with sponsors .
Provides training and education for patient care staff in all aspects of trial initiation, conduct and closure.
Serves as primary contact for subjects, sponsors and staff of research related University offices and hospital departments in nursing, pharmacy, billing, medical records related to assign studies.
Travel to attend investigator’s meeting presented by study sponsors.
Identify and recruit study subjects - screen regularly to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff, and by reviewing medical data.
Recruit patients and explain protocol and consent forms. Assure original signed consent forms are maintained in the study binder.
Data entry – complete source documents and worksheets and complete and/or enter all clinical record forms (CRFs) in a timely manner. Obtain records required to complete CRFs. Resolve data queries.
Organize and coordinate study procedures – schedule study visits within protocol designated time frames; assure research orders and billing information are properly entered into the electronic medical record; ensure protocol dictated patient remuneration.
Sample processing – process, label, and store human subject blood samples according to study protocol. Help manage sample inventory.
Follow-up telephone calls/interview – conduct study visits, including administering questionnaires, escorting patients to protocol-required tests and procedures.
Assist with completing and maintaining regulatory correspondence under the direction of research director.
Participate in monitoring visit/ audit preparation and follow-up.
Provide subject and family education and support. Ensure subjects are educated regarding the protocol specifics and study drugs/devices.
Assist interventionalists in investigational device trials, device dispensing/accountability.
Perform additional duties as assigned.
Provide in service training and education to PPMC inpatient/cath lab cardiology nurses.
Support and train new research coordinator.
Review all new trials in the cath lab to help identify the challenges and implement a plan to solve the challenges.

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.