Clinical Research Coordinator - Medicine

POSITION SPECIFICS Position Overview / Job Description

The Department of Medicine at the Penn State College of Medicine in Hershey, PA is seeking a Clinical Research Coordinator. The Clinical Research Coordinator will provide dedicated operational and administrative support to the Principal Investigator and study team in the coordination, execution, and ongoing management of clinical research studies within an academic medical center environment. This position will support the full lifecycle of clinical research activity, with particular emphasis on patient identification, recruitment, screening, enrollment coordination, study documentation, regulatory readiness, data collection, and communication with patients, clinical teams, research offices, sponsors, and institutional partners.

The role is designed to strengthen the Principal Investigator's ability to activate, manage, and successfully enroll patients into clinical studies while ensuring that research activities are conducted in accordance with approved protocols, institutional requirements, human subjects protection standards, Good Clinical Practice expectations, and applicable federal, state, and University policies.

The Clinical Research Coordinator will serve as a key operational liaison between the Principal Investigator, clinical care teams, research participants, the Clinical Trials Office, IRB/HRPP, sponsors, and other internal and external stakeholders. The position requires strong organization, careful documentation, clear communication, patient-centered professionalism, and the ability to manage multiple study-related priorities in a highly regulated clinical and academic setting.

1. Patient Identification, Screening, and Recruitment

Identify potentially eligible patients for clinical research studies through approved recruitment methods, including review of clinic schedules, provider referrals, registries, EMR-based reports, and study-specific screening tools. Coordinate with the Principal Investigator and clinical team to determine preliminary eligibility and support timely outreach to potential participants.

2. Participant Communication and Enrollment Support

Serve as a point of contact for potential and enrolled research participants. Explain study-related processes within the scope of the role, coordinate recruitment communications, assist with scheduling screening or study visits, and support a professional and patient-centered participant experience.

3. Study Visit Coordination

Coordinate study-related appointments, participant follow-up, research assessments, laboratory or procedural scheduling, and communication with clinical and ancillary teams. Ensure that study visits are organized, protocol-aligned, and appropriately documented.

4. Protocol and Regulatory Support

Assist with the preparation, submission, maintenance, and organization of study documentation, including IRB materials, consent documents, recruitment materials, delegation logs, training records, regulatory binders, protocol amendments, continuing reviews, and reportable event documentation as directed by the Principal Investigator or research leadership.

5. Data Collection and Documentation

Collect, enter, track, and reconcile study data using approved systems and source documents. Maintain accurate, complete, and timely research records, including screening logs, enrollment logs, case report forms, participant tracking tools, and study-specific documentation.

6. Operational Coordination for the Principal Investigator

Support the Principal Investigator in managing study timelines, deliverables, recruitment goals, meeting preparation, sponsor communications, study start-up tasks, and ongoing operational needs. Track open items and help ensure follow-through on study-related commitments.

7. Compliance and Quality Assurance

Support compliance with study protocols, institutional policies, human subjects protection requirements, Good Clinical Practice standards, and applicable federal and state regulations. Assist with internal monitoring, audit preparation, query resolution, and corrective action tracking as needed.

8. Collaboration with Clinical and Research Teams

Coordinate workflows between the Principal Investigator, clinical providers, nursing teams, schedulers, ancillary departments, Clinical Trials Office staff, IRB/HRPP contacts, sponsors, CROs, and other stakeholders. Communicate clearly and promptly to support safe, compliant, and efficient study execution.

9. Study Start-Up and Maintenance Activities

Assist with study activation activities, including feasibility preparation, site initiation support, study tool development, workflow planning, staff training coordination, and creation of study-specific operating procedures, templates, and tracking tools.

10. Recruitment Performance Tracking

Monitor recruitment activity, screening outcomes, enrollment metrics, reasons for screen failure, and barriers to enrollment. Provide regular updates to the Principal…