Clinical Research Regulatory Coordinator | Oncology Therapeutics

The Pennsylvania State University; États-Unis; Sur place; USD 54 000 - 86 000; Plein temps

Avantages offerts par ce poste

75% tuition discount

Competitive benefits

Paid time off

Résumé du poste

The Pennsylvania State University in Hershey, PA seeks a Clinical Research Regulatory Coordinator to manage regulatory affairs for Oncology trials conducted by the Experimental Therapeutics (Extract) Team. You will prepare IRB applications, maintain regulatory files, and monitor approvals and deadlines.

You will serve as primary regulatory contact, ensure compliance with FDA, ICH-GCP, and institutional policies, coordinate submissions with sponsors and CROs, and support audit readiness and study

Qualifications

• Bachelor's degree required with 3+ years of relevant experience or equivalent combination.
• Experience coordinating regulatory start-up and maintenance across industry-sponsored and investigator-initiated trials.
• Knowledge of FDA regulations and ICH-GCP guidelines.

Responsabilités

• Coordinate regulatory start-up and activation activities for oncology trials.
• Prepare and submit IRB applications, amendments, and continuing reviews.
• Maintain regulatory files and ISFs; monitor approvals and deadlines.
• Serve as primary regulatory contact for assigned trials and ensure audit readiness.

Connaissances

Regulatory coordination

Oncology trials

FDA regulations

ICH-GCP

IRB submissions

Regulatory documentation management

Formation

Bachelor's Degree

Outils

IRB management systems

Description du poste

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

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.

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.

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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