Clinical Research Coordinator A

University of Pennsylvania•Philadelphia, PA

2d•Onsite

About The Position

The Renal division in the department of medicine supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated trials. This position is responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte, and Hypertension Division. The position involves working directly with study physicians, research nurses, and other research staff at Penn and at other sites. The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working off site and flexible hours.

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination education and experience is required.
Effective problem solving abilities
effective communication and writing skills
strong organizational and time management skills
flexible and able to multi-task
demonstrated ability to work as part of a team, as well as independently
knowledge of IRB and human research protection regulations

Nice To Haves

prior experience in gene therapy trials preferred

Responsibilities

Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs, processing and shipping of biological specimens and manage study data and regulatory files per GCP. Also includes: subject recruitment, informed consent, chart maintenance and data entry.
Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
Ordering and stocking supplies, maintaining equipment
With supervision, assist in preparation of research protocols and documents.
With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks.
Attend Investigator Meetings and communicate meeting information to the study team.
Perform additional duties as assigned CONTINGENT UPON FUNDING

Benefits

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
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
tuition assistance for employees, spouses, and dependent children
tuition assistance for dependent children at other institutions
generous retirement plans
pre-tax or Roth basis retirement savings
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 resources
access to a wide range of University resources as well as cultural and recreational activities
free or discounted admission and memberships to Penn arts and cultural centers and museums
discounts on goods and services such as new cars, cellular phone service plans, movie tickets, and admission to theme parks
flexible work options
forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
adoption assistance