Clinical Research Coordinator A/B/C

University of Pennsylvania

4d•$47,313 - $70,000•Onsite

About The Position

As part of the Department of Medicine, the DOM Clinical Trials Unit 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, different disease states and varying complexities. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics. To learn more about DOM CTU visit https://www.med.upenn.edu/pennctu/.

Requirements

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
Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required (CRC-A).
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required (CRC-B).
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required (CRC-C).

Nice To Haves

Less supervision in the management of clinical trials and will need to use more independent judgment (CRC-B).
Perform the duties above with more limited supervision from the project manager (CRC-C).
Management of clinical trials and will need to use more independent judgment (CRC-C).

Responsibilities

Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit.
Support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities.
Assist in development of study documents.
Work with Regulatory Specialist for regulatory submissions.
Communicate with study team members.
Recruit, consent, and screen patients according to protocol.
Schedule patient visits and any necessary testing.
Conduct patient visits.
Monitor patients per protocol requirements and ensure adherence to protocol requirements.
Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts.
Collect, review, and report study data.
Complete case report forms and resolve data queries.
Process and ship study specimens including blood and urine.
Participate in initiation, monitoring, audit, and close-out visits.
Participate in study team meetings and ongoing protocol training.
Assist in the development and maintenance of study specific case report forms and source document tools.
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, FDA, and GCP guidelines.
Develop study specific source documents and trackers (CRC-B).
Prepare and submit regulatory packages (CRC-B).
Correspond with sponsor & regulatory review boards (CRC-B).
Help with study start-up activities (CRC-B).
Develop complex documents such as protocols and consents (CRC-C).
Lead team meetings (CRC-C).
May take a lead role in study communication with internal and external groups (CRC-C).
Work directly with investigators to design, set-up and execute studies (CRC-C).
Accountable for making sure study timelines and goals are met (CRC-C).
Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required (CRC-C).

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 (Basic, Matching, and Supplemental)
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
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 options
Penn Home Ownership Services (forgivable loan for eligible employees)
Adoption Assistance