Clinical Research Coordinator B/C

The Trustees of the University of Pennsylvania seek a Clinical Research Coordinator B/C to implement clinical research activities in the Cardiovascular Division of PPMC. The role coordinates and supports industry-sponsored clinical trials, including participant recruitment and follow-up, data and sample management, regulatory documentation, and support for investigators and study staff.

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

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
• Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition assistance for you, your spouse, and your dependent children at Penn; dependent children are also eligible for tuition assistance at other institutions.
• Basic, Matching, and Supplemental retirement plans, with a variety of investment options through TIAA and Vanguard.
• A substantial amount of time away from work during the course of the year.
• Long-term care insurance for faculty and staff and eligible family members. If faculty or staff apply when newly hired, proof of good health and underwriting requirements are waived; eligible family members must provide proof of good health and are subject to underwriting.
• Wellness and work-life programs and resources.
• Professional and personal development resources.
• Access to University libraries, athletic facilities, cultural and recreational activities; you and your family can enjoy many activities for free.
• Discounts and special services, including free and discounted admission and memberships at Penn arts and cultural centers and museums, and savings on other goods and services such as new cars, cellular phone service plans, movie tickets, and theme park admission.
• Flexible work options involving non-traditional work hours, locations, and/or job structures.
• A forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, usable for closing costs or home improvements.
• Reimbursement for eligible employees’ 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.

Company

• Ivy League university offering undergraduate and graduate education
• Philadelphia, Pennsylvania, USA
• http://www.upenn.edu/
• Founded in 1740
• 10001+ employees

Qualifications

• 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
• 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.

Required skills

Experience

• 2+ years