Clinical Research Coordinator - Medicine

The Pennsylvania State University; United States; On-site; USD 1,200 - 86,000; Full time

Job summary

The Pennsylvania State University in Hershey, PA is seeking a Clinical Research Coordinator to provide operational and administrative support to the Principal Investigator and study team across the full lifecycle of clinical studies at an academic medical center. You will identify eligible patients, coordinate enrollment, manage study documentation, and ensure regulatory readiness.

The role requires strong organization, meticulous attention to detail, and excellent communication as you interface

Qualifications

• Bachelor's degree is required.
• 3+ years of relevant clinical research experience.
• Familiarity with IRB/HRPP processes and GCP standards.
• Experience with EMR workflows, REDCap and CTMS.
• Strong organizational and communication skills.

Responsibilities

• Identify eligible patients for studies and coordinate recruitment.
• Coordinate study visits, screenings, and participant communications.
• Prepare and organize regulatory documents and IRB materials.
• Collect and manage study data with source documents.
• Support startup activities, timelines, and sponsor communications.
• Ensure compliance with GCP and institutional policies.
• Collaborate with PI, clinical teams, and sponsors.

Skills

IRB processes

GCP compliance

EMR workflows

REDCap

CTMS

Sponsor communication

Healthcare research

Education

Bachelor's Degree

Job description

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.

Core Responsibilities

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 Investigator and study team and assist in developing practical strategies to improve recruitment and retention.
11. 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.
12. 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.
13. 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.
14. 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

Background Checks/Clearances

Employment with the University will require successful completion of background check(s) in accordance with University policies. Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S.

Salary & Benefits

The salary range for this position, including all possible grades, is $59,580.00 - $86,400.00.

Salary Structure - Information on Penn State's salary structure

Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page.

Campus Security Crime Statistics

Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here.

EEO IS THE LAW

Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473. Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission.

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