POSITION SPECIFICS

The Penn State College of Medicine, Department of Pediatrics, in Hershey, PA, is seeking a motivated and experienced Clinical Coordinator Manager to lead and supervise a team of clinical research coordinators responsible for supporting clinical trials and other human subjects research activities within the Department of Pediatrics at the Penn State College of Medicine. The Clinical Coordinator Manager will ensure that clinical research projects are executed in compliance with all regulatory, institutional, and sponsor requirements and will work closely with investigators, research staff, and leadership to promote excellence in clinical trial operations.

PREFERRED QUALIFICATIONS:

• Master’s degree in a health-related or scientific field preferred.
• Minimum of 5 years of experience in clinical research
• Strong knowledge of clinical trial regulations, human subject protections, and good clinical practice (GCP).
• Excellent interpersonal, organizational, and communication skills.
• Experience with electronic data capture systems and clinical trial management systems (CTMS) preferred.Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) certification (e.g., ACRP, SOCRA) is highly desirable.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

Master’s Degree 3+ years of relevant experience; or an equivalent combination of education and experience accepted Required Certifications: None

PREFERRED QUALIFICATIONS:

• Master’s degree in a health-related or scientific field preferred.
• Minimum of 5 years of experience in clinical research
• Strong knowledge of clinical trial regulations, human subject protections, and good clinical practice (GCP).
• Excellent interpersonal, organizational, and communication skills.
• Experience with electronic data capture systems and clinical trial management systems (CTMS) preferred.Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) certification (e.g., ACRP, SOCRA) is highly desirable.

• Supervise, train, and support a team of clinical research coordinators and/or specialists.
• Oversee daily operations of assigned clinical trials, ensuring adherence to study protocols and applicable regulations (e.g., FDA, GCP, IRB).
• Collaborate with investigators and study teams to develop study timelines, monitor progress, and resolve operational issues.
• Serve as a resource to research staff for protocol interpretation, regulatory guidance, and best practices in study conduct.
• Ensure accurate and timely data collection, reporting, and documentation.
• Participate in hiring, onboarding, and performance evaluations of staff.
• Maintain current knowledge of institutional, federal, and sponsor policies related to human subjects research.
• Contribute to continuous process improvement initiatives in clinical research management.