Clinical Research Coordinator A

University of Pennsylvania•Philadelphia, PA

5d•Onsite

About The Position

Assist in the coordination of Phase I – IV clinical trials. Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor. Conduct data entry in CRFs as provided by the study sponsor Organize study start up and generate materials to support trial workflows. Navigate eligibility criteria. Develop recruitment strategies to poise trial for success. Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns. Serve as an overall resource or point of contact for individuals interested in clinical trials. Resolve data queries with sponsor and CROs. Ensure data monitoring accuracy. Recruit, screen and enroll potential study subjects as specified per protocol. Utilize the EMR to support and operationalize clinical research. Provide study related metrics and tracking. Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required. Process and ship blood, urine, and serum specimens for each trial. Schedule patient visits and any necessary testing. Attend Investigator Initiation meetings. Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines. Obtain records required to complete case report forms. Assist in the preparation of documents needed for initiation, monitoring and closeout visits with sponsors and/or CROs. Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, informed consent form (ICF), and FDA guidelines. Assist PI with presentations and publications

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
Effective problem-solving skills
Effective verbal and written communication skills
Ability to learn new methods quickly and multi-task
Demonstrated ability to work as part of a team as well as independently
Ability to work flexible hours
Knowledge of IRB and Human Research Protection Regulations
Experience in Microsoft word and excel.

Nice To Haves

1- 2 years of clinical trial/clinical research experience

Responsibilities

Assist in the coordination of Phase I – IV clinical trials
Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor
Conduct data entry in CRFs as provided by the study sponsor
Organize study start up and generate materials to support trial workflows
Navigate eligibility criteria
Develop recruitment strategies to poise trial for success
Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns
Serve as an overall resource or point of contact for individuals interested in clinical trials
Resolve data queries with sponsor and CROs
Ensure data monitoring accuracy
Recruit, screen and enroll potential study subjects as specified per protocol
Utilize the EMR to support and operationalize clinical research
Provide study related metrics and tracking
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required
Process and ship blood, urine, and serum specimens for each trial
Schedule patient visits and any necessary testing
Attend Investigator Initiation meetings
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines
Obtain records required to complete case report forms
Assist in the preparation of documents needed for initiation, monitoring and closeout visits with sponsors and/or CROs
Show vigilance in patient safety, protocol compliance, and data quality
Adhere to all University of Pennsylvania, informed consent form (ICF), and FDA guidelines
Assist PI with presentations and publications
Assist in the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to the University of Pennsylvania Institutional Review Board (IRB)
Assist in the preparation and processing of regulatory documentation with pharmaceutical companies and CROs
Assist in obtaining the appropriate signatures for regulatory forms
Organize and maintain all documentation required by sponsor or CRO
Resolve regulatory related queries with sponsors and CROs.

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.