Clinical Research Regulatory Coordinator | Oncology Therapeutics

The Pennsylvania State University; Hershey (PA); On-site; USD 54,000 - 86,000; Full time

Benefits offered by this job

Tuition discount 75%

Robust retirement plans

Paid time off

Job summary

The Pennsylvania State University in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for Oncology trials conducted by the Extract Team at Penn State College of Medicine. This role supports start-up, activation, ongoing maintenance, and closeout across an assigned portfolio.

You will ensure FDA/ICH-GCP compliance, prepare IRB submissions, maintain regulatory files, and collaborate with investigators, coordinators, sponsors, CROs, and regulatory

Qualifications

• Bachelor's Degree and 3+ years of regulatory experience.
• Experience with FDA regulations, IND studies, and ICH-GCP.
• Proficiency with IRB submissions and regulatory documents.

Responsibilities

• Coordinate regulatory start-up and activation for oncology trials.
• Prepare IRB applications, amendments, and continuing reviews.
• Maintain Investigator Site Files and regulatory documents.
• Ensure study compliance and audit readiness throughout closeout.

Skills

Regulatory management

IRB submissions

Oncology trials

Regulatory compliance

Communication

Education

Bachelor's Degree

3+ years of relevant experience

Tools

Electronic regulatory document management systems

Job description

Approval of remote and hybrid work is not guaranteed regardless of work location.For additional information on remote work at Penn State, seeNotice to Out of State Applicants.

This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.

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.

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 Degree3+ years of relevant experience; or an equivalent combination of education and experience acceptedRequired Certifications:NoneIf filled as Clinical Research Coordinator - Intermediate Professional, this position requires:Bachelor's Degree1+ years of relevant experience; or an equivalent combination of education and experience acceptedRequired 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.

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.