Clinical Research Regulatory Coordinator | Oncology Therapeutics

Penn State University•Tallahassee, FL

18h•$54,060 - $86,400

About The Position

The Penn State College of Medicine in Hershey, Pennsylvania, is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for oncology clinical trials conducted by the Experimental Therapeutics (Extract) Team. The coordinator independently manages an assigned portfolio of trials through study start-up, activation, ongoing maintenance, and closeout. Working with Principal Investigators, clinical research staff, sponsors, contract research organizations, and institutional regulatory offices, the coordinator supports compliance with institutional policies, FDA regulations, and Good Clinical Practice guidelines. The position supports Phase I, II, and III oncology therapeutic trials, including trials involving investigational agents and novel cancer treatments. The position is funded for one year. Continuation beyond one year depends on university need, performance, and/or funding availability. Remote or hybrid work is not guaranteed.

Requirements

For the Advanced Professional level: Bachelor's degree and at least 3 years of relevant experience, or an equivalent combination of education and experience.
For the Intermediate Professional level: Bachelor's degree and at least 1 year of relevant experience, or an equivalent combination of education and experience.
Applicants must be authorized to work in the United States; Penn State does not sponsor or take over sponsorship of staff employment visas.
Required certifications: None.

Nice To Haves

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.
Strong organizational skills and the ability to independently manage multiple studies and competing deadlines.

Responsibilities

Coordinate regulatory start-up and activation 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, current regulatory files and Investigator Site Files.
Monitor regulatory approvals, expiration dates, training requirements, and compliance deadlines.
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.
Maintain audit- and inspection-ready regulatory files and 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.
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.