"Clinical Research Coordinator A/B"

Clinical Research Coordinator A/B

Job Description Summary

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.

Preferred Skills and Experience

• 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

Job Responsibilities

Clinical Research Coordinator A

• 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.

In addition to the duties of the Clinical Research Coordinator A, the Clinical Research Coordinator B:

• 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.

Qualifications:

• 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

Job Location: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $46,500.00 - $52,661.00 Annual Rate

Position is contingent on continued funding. Currently, we are only able to consider candidates who are authorized to work in the country without the need for visa sponsorship.

To apply: https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Pennsylvania-Hospital/Clinical-Research-Coordinator-A-B_JR00118406