Clinical Research Coordinator - Medicine

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.

Core Responsibilities

• 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.
• Participant Communication and Enrollment
• Support 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.
• 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.
• Protocol and Regulatory Support
• Aid in 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.
• 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.
• 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.
• 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.
• Collaboration with Clinical and Research Teams
• Cook up 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.
• Study Start-Up and Maintenance Activities
• Aid in 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.
• Recruitment Performance Tracking
• Maintain recruitment activity, screening outcomes, enrollment metrics, reasons for screen failure, and barriers to enrollment. Provide regular updates to the Principal Investigator and study team and assist in developing practical strategies to improve recruitment and retention.
• Participant Retention and Follow-Up
• Track participant follow-up requirements, upcoming study visits, required assessments, and retention milestones. Help ensure participants remain engaged and that required study activities are completed within protocol-defined windows.
• Budget and Resource Awareness
• Support study-related resource tracking as assigned, including participant reimbursement documentation, invoice support, supply tracking, and communication of operational needs that may affect study timelines or feasibility.
• Training and Certification Tracking
• Maintain documentation of required training for study personnel, including protocol-specific training, CITI/GCP training, delegation logs, and other institutional or sponsor-required certifications.
• Professional Representation of the Research Program
• Represent the Principal Investigator and department professionally in communications with patients, families, clinical teams, research administration, sponsors, and external partners. Maintain confidentiality, discretion, and a high level of responsiveness.

Preferred Qualifications

• Experience supporting clinical research studies in an academic medical center or health system environment.
• Familiarity with IRB processes, human subjects research requirements, Good Clinical Practice, clinical trial documentation, EMR workflows, REDCap or similar data capture tools, CTMS systems, and sponsor or CRO communication.
• Strong organizational skills, attention to detail, professional communication, and the ability to coordinate work across clinical, research, and administrative teams.

Minimum Education, Work Experience & Required Certifications

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