Clinical Research Coordinator A/B

University of Pennsylvania•Philadelphia, PA

About The Position

The Clinical Research Coordinator A/B supports research studies focused on obstructive sleep apnea (OSA) and related physiological testing in adult humans. This individual coordinates all aspects of study execution, including participant recruitment, study visits, data collection, and supports regulatory compliance activities. This role ensures that studies are conducted according to protocol and Good Clinical Practice (GCP) guidelines, facilitates accurate documentation and reporting, and serves as a liaison among participants, investigators, and study sponsors. The coordinator plays a key role in advancing OSA research by ensuring reliable data collection and proper documentation throughout each study.

Requirements

Clinical Research Coordinator A, Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required
Clinical Research Coordinator B, Bachelor's Degree with 2-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required

Nice To Haves

Experience coordinating research activities, including subject enrollment, data collection and analysis, and database management
Experience working in a clinical environment with a strong working knowledge of health data systems
Excellent interpersonal and communication skills, particularly the ability to explain topics and concepts in an easy-to-understand and accessible manner, both verbally and in writing
Excellent organizational skills, including practical problem-solving abilities and strong attention to detail
Working knowledge of Microsoft Office, particularly Outlook, Word, Excel, and PowerPoint
Experience with REDCAP database management or entry level coding is desirable
Background in sleep medicine or sleep technology is desirable

Responsibilities

Ensures proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation.
Prepares Institutional Review Board (IRB) documents in collaboration with the regulatory team, including initial IRB submissions, amendments, continuing reviews, and reportable events.
Coordinates, organizes, and maintains all sponsor or CRO-required documentation, including case report forms, source documentation, study and regulatory binders, and subject binders.
Coordinates all aspects of clinical trials, including participant management, device handling (for IDE studies), regulatory compliance, and study documentation.
Participates in sponsor, CRO, FDA, and other required audits.
Schedules patient visits and any required testing.
Adheres to all University of Pennsylvania, Institutional Review Board (IRB), and FDA regulations and guidelines.
Supports sponsor and CRO interactions, including participation in study initiation, monitoring, and closeout visits.
Supports the project manager and investigators in providing guidance and oversight to the CRC-A and research assistant(s) to support efficient study operations and adherence to study protocols.
Independently manages study coordination activities, including participant recruitment, screening, and enrollment.
Leads the preparation and submission of IRB documentation, including initial submissions, amendments, continuing reviews, and reportable events.
Maintains study regulatory documentation and ensures compliance with sponsor, institutional, and federal requirements.
Serves as the primary coordinator during sponsors, CRO, and regulatory bodies during monitoring visits and audits.
Coordinates cross-functional study activities, including communication with investigators, sponsors, and ancillary departments.

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.