Clinical Research Coordinator C

University of Pennsylvania

2d•$62,000 - $63,854•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for the execution of clinical research studies within the Department of Neurology's Stroke Division at the University of Pennsylvania. The candidate will carry out daily activities related industry-sponsored and federally-funded research protocols, as well as assist in the conduct of investigator-initiated research and division-specific research projects and operations. • Coordinate the conduct of Stroke division clinical trials, including but not limited to: o Screening, recruiting and enrolling potential study patients as specified per protocol o Data management, including data entry and query resolution o Process and ship blood, urine, and serum specimens as specified per protocol o Adhering to the study protocol schedule of assessments, including scheduling patient visits and conducting visits • Participate in the conduct of audits by study sponsors, Clinical Research Organizations (CROs), the FDA, and other entities as required. • Active participation in the development of investigator-initiated protocol case report forms and progress notes • Conduct initiation, monitoring and closeout visits with sponsors and/or CROs. • Organize and maintain all documentation required by sponsor or CRO (source documentation, case report forms, study and regulatory binders, and patient binders). • Attend Investigator Initiation meetings • Show vigilance in patient safety, protocol compliance, and data quality. • Adhere to all University of Pennsylvania, ICF, and FDA guidelines. • Ability to start up and support multi-site trials • Ability to operationalize a clinical research protocol and build synergistic partnerships • Assist the Associate Director in keeping track of patient visits and activities for billing and invoicing • Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting. • Prepare and process all regulatory documentation with pharmaceutical companies and CROs • Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance). • Resolve regulatory related queries with IRB, study sponsors and CROs. • Provide mentorship for more junior clinical research staff This position is contingent upon funding.

Requirements

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
Must be detail-oriented with organizational and multi-tasking skills.
Excellent interpersonal and communication skills.
Must have a strong ability to communicate with clinicians, researchers, patients and families.
Ability to work with a diverse group of people
Must be able to exercise discretion with confidential information

Nice To Haves

Prior experience with IRB guidelines, policies, human subject research practices and appropriate professional skills in the execution of research protocols is preferred
Due to varying study protocol designs and stringent project deadlines, candidates should have the ability to occasionally work outside of normal work week hours.
Job may require communication with staff and patients outside of office hours.

Responsibilities

Coordinate the conduct of Stroke division clinical trials, including but not limited to: Screening, recruiting and enrolling potential study patients as specified per protocol, Data management, including data entry and query resolution, Process and ship blood, urine, and serum specimens as specified per protocol, Adhering to the study protocol schedule of assessments, including scheduling patient visits and conducting visits
Participate in the conduct of audits by study sponsors, Clinical Research Organizations (CROs), the FDA, and other entities as required.
Active participation in the development of investigator-initiated protocol case report forms and progress notes
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Organize and maintain all documentation required by sponsor or CRO (source documentation, case report forms, study and regulatory binders, and patient binders).
Attend Investigator Initiation meetings
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Ability to start up and support multi-site trials
Ability to operationalize a clinical research protocol and build synergistic partnerships
Assist the Associate Director in keeping track of patient visits and activities for billing and invoicing
Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and CROs
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs.
Provide mentorship for more junior clinical research staff

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.