Clinical Research Coordinator A/B/C

Perelman School of Medicine at the University of Pennsylvania•Philadelphia, PA

80d

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/. Clinical Coordinator A: Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit. The person will 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. Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as: 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 qualify. Adhere to all University of Pennsylvania, FDA, and GCP guidelines. Clinical Coordinator B, in addition to the above, will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities. The CRC B will have less supervision in the management of clinical trials and will need to use more independent judgment. Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the project manager. In addition, will develop complex documents such as protocols and consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials and will need to use more independent judgment.

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 for CRC-A
Bachelor of Science and 2 to 4 years of experience or equivalent combination of education and experience is required for CRC-B
Bachelor of Science and 4+ years of experience or equivalent combination of education and experience is required for CRC-C

Responsibilities

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 qualify.
Adhere to all University of Pennsylvania, FDA, and GCP guidelines.
Develop study specific source documents and trackers
Prepare and submit regulatory packages
Correspond with sponsor & regulatory review boards
Help with study start-up activities
Develop complex documents such as protocols and consents
Lead team meetings
Take a lead role in study communication with internal and external groups
Work directly with investigators to design, set-up and execute studies
Accountable for making sure study timelines and goals are met
Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required

Benefits

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.
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.
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.
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.
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.
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.
Penn provides an array of resources to help you advance yourself personally and professionally.
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.
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 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 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.
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.