Clinical Research Regulatory Coordinator | Oncology Therapeutics

Clinical Research Regulatory Coordinator

The Penn State College of Medicine, in Hershey, PA is seeking a Clinical Research Regulatory Coordinator. This position is responsible for the regulatory management of Oncology clinical trials conducted by the Experimental Therapeutics (Extract) Team at Penn State College of Medicine. This position independently manages regulatory activities across an assigned portfolio of oncology clinical trials, supporting study start-up, activation, ongoing maintenance, and closeout.

Working closely with Principal Investigators, clinical research staff, sponsors, contract research organizations (CROs), and institutional regulatory offices, the coordinator ensures regulatory compliance with institutional policies, FDA regulations, and Good Clinical Practice (GCP) guidelines.

The ideal candidate will have experience in clinical research regulatory affairs, preferably within oncology therapeutics, strong organizational skills, and the ability to independently manage multiple studies and competing deadlines.

Essential Duties and Responsibilities

1. Regulatory Study Start-Up and Maintenance

• Coordinate regulatory start-up and activation activities for industry-sponsored, investigator-initiated, cooperative group, and federally sponsored oncology trials.
• Prepare and submit initial IRB applications, continuing reviews, protocol amendments, informed consent revisions, personnel changes, and other required regulatory submissions.
• Collect, review, and maintain essential regulatory documents, including protocols, investigator brochures, CVs, licenses, training records, and financial disclosures.
• Independently manage regulatory requirements and submission timelines for an assigned portfolio of clinical trials.
• Maintain accurate, complete, and current regulatory files and Investigator Site Files (ISFs).
• Monitor regulatory approvals, expiration dates, training requirements, and compliance deadlines.

2. Oncology-Specific Regulatory Compliance

• Provide regulatory support for Phase I, II, and III oncology therapeutic clinical trials involving investigational agents and novel cancer treatments.
• Coordinate regulatory documentation and requirements associated with IND studies, investigational products, safety updates, and protocol amendments.
• Ensure compliance with applicable FDA regulations, ICH-GCP guidelines, and institutional research policies.
• Identify and address regulatory deficiencies and ensure study documentation remains current and compliant.

3. Quality Assurance and Study Closeout

• Maintain regulatory files in an audit- and inspection-ready state.
• Coordinate preparation for sponsor monitoring visits, internal audits, and regulatory inspections.
• Perform quality checks to ensure regulatory documentation is accurate, complete, and compliant.
• Coordinate final regulatory submissions, IRB study closure, and long-term document archiving

4. Communication and Collaboration

• Serve as a primary regulatory contact for assigned oncology clinical trials.
• Collaborate with investigators, clinical research coordinators, research nurses, sponsors, CROs, and institutional regulatory personnel.
• Communicate regulatory requirements, timelines, and outstanding documentation needs to research team members.
• Contribute to regulatory process improvements and support research staff with study-specific regulatory requirements.

Preferred Qualifications

• Previous experience in oncology clinical research, preferably supporting oncology therapeutic clinical trials.
• Experience with Phase I, II, and/or III oncology clinical trials.
• Experience with regulatory submissions for industry-sponsored, investigator-initiated, and cooperative group oncology studies.
• Familiarity with FDA regulations, IND studies, and ICH-GCP guidelines.
• Experience with IRB submissions and electronic regulatory document management systems.

Minimum Education, Work Experience & Required Certifications

If filled as Clinical Research Coordinator - Advanced Professional, this position requires:

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

If filled as Clinical Research Coordinator - Intermediate Professional, this position requires:

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

Background Checks/Clearances

This position requires the following clearances in addition to applicable background checks: PA State Police Criminal Background Check, PA Child Abuse History Clearance Form, and Federal (FBI) Fingerprint Criminal Background Check. 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 $54,060.00 - $86,400.00.

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.