Clinical Research Coordinator A

University of Pennsylvania

1d•Onsite

About The Position

The Penn Neurogenetics Therapy Center is seeking a highly motivated and detail-oriented Clinical Research Coordinator A (CRC A) who will be responsible for the coordination of assigned industry-sponsored, federally-funded and/or investigator-initiated clinical studies through their entire lifecycle (startup, conduct and closeout).

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
The CRC A should be highly motivated and detail-oriented, have strong planning, organizational, multi-tasking, and prioritizing capabilities.
The CRC A should possess the ability to work independently and also as part of a team.
The CRC A should have a strong ability to communicate with clinicians, researchers, sponsors, patients and families.

Nice To Haves

Prior experience with industry-sponsored trials, start-up activities (financial and regulatory), ethics committees, human subject research policies and practices are preferred.

Responsibilities

Reviewing and comprehending assigned protocols, including study procedures and timelines, to ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement
Facilitating the approval of new study agreements and contracts
Assisting with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), study logs
Recruiting and enrolling study participants, coordinating study visits and serving as liaison between the participant, PI, members of the study team and external Sponsor/CRO teams
Collecting clinical data, completing source documents, and collecting, processing and shipping biological samples
Completing electronic case report forms according to source documents and responding to data clarification requests in a timely manner
Establishing and maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required
Preparing and managing regulatory submissions and inquiries
Coordinating and attending Investigator Meetings, Site Selection visits, routine monitoring visits, and study close out visits
As applicable, the CRC A will work closely with the study PI and PNTC study team to identify problems, develop solutions, implement approved changes to procedures and monitor results.
As applicable, the CRC A will train junior members of the research team.
Depending on study assignment, the CRC may complete research activities at the Hospital of the University of Pennsylvania (primary location), Pennsylvania Hospital (PAH) and/or Children’s Hospital of Philadelphia (CHOP).
The position may require communication with patients and staff outside of office hours.
The CRC A will promote institutional values of patient and visitor satisfaction by demonstrating courtesy and respect for patients and their families, visitors and other employees.
The CRC A will demonstrate competence in the assessment, treatment and care of patients, and is expected to exhibit a professional and compassionate demeanor in performance of responsibilities and to be unfailingly responsive to the needs of patients.

Benefits

excellent healthcare
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 here at Penn for employees, spouses, and dependent children
tuition assistance at other institutions for dependent children
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
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
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
forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
reimbursement for qualified expenses in connection with the legal adoption of an eligible child