Clinical Research Regulatory Coordinator | Oncology Therapeutics

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

Benefits offered by this job

75% tuition discount

Retirement plans

Paid time off

Job summary

The Penn State College of Medicine in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics (Extract) Team. This role supports study start-up, activation, ongoing maintenance, and closeout.

The ideal candidate has oncology regulatory experience, strong organization, and the ability to manage multiple studies and deadlines independently.

Qualifications

• Bachelor's Degree with relevant experience or equivalent combination.
• Experience with regulatory submissions for oncology trials preferred.
• Knowledge of FDA regulations, INDs, and ICH-GCP guidelines.

Responsibilities

• Regulatory study start-up and maintenance for oncology trials.
• Prepare and submit IRB applications and amendments.
• Maintain regulatory files and ISFs with timely submissions.
• Coordinate with investigators, sponsors, CROs and regulatory offices.

Skills

Regulatory management

Oncology trials

IRB submissions

FDA regulations

ICH-GCP guidelines

Independent study management

Education

Bachelor's Degree 3+ years experience

Bachelor's Degree 1+ years experience

Tools

Electronic regulatory documents 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, see Notice 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.

POSITION SPECIFICS

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

• 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.
• 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.
• 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
• 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.

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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