Compliance Specialist - Cancer Institute

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POSITION SPECIFICS

The Penn State College of Medicine, Cancer Institute in Hershey, PA is seeking a Compliance Specialist.

This position would be responsible to assist clinical investigators with the implementation of all Cancer Institute clinical research protocols, to include administrative and regulatory aspects of study start-up, maintenance, and closure. 50% of role will be to coordinate and manage study start-up activities including site identification, feasibility, and selection. Prepare, review, and submit regulatory documents to ethics committees, institutional review boards (IRBs), and regulatory authorities. Track and manage essential documents in accordance with ICH-GCP and company SOPs. Liaise with internal teams, clinical sites, and external sponsors to ensure timely completion of start-up milestones. Maintain up-to-date knowledge of regulatory requirements and ensure compliance across all study start-up activities. Support contract and budget negotiations in collaboration with legal and finance teams. Assist in the development and maintenance of study-specific regulatory trackers and reports. Responsible for maintaining compliance with both internal (e.g., ORA, IRB) and external (e.g., FDA, NCI) requirements. This individual will drive processes to ensure efficient and compliant study activation and maintenance, with attention to metrics driven goals for productivity. They will ensure all files are maintained in an audit-ready fashion.

KNOWLEDGE, SKILLS, & ABILITIES:

• Proficiency with Microsoft Office required as well as the ability to learn an internal clinical trials management application.
• Excellent organizational and time management skills required.
• The ability to multi-task, prioritize, and work independently are required.
• Excellent written and verbal communication is required.

PREFERRED QUALIFICATIONS:

• Knowledge of clinical trials management, including local and federal regulatory requirements preferred.
• SoCRA or ACRP Certification preferred.
• Administrative and/or regulatory experience in clinical trials, academic research or health care.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

BACKGROUND CHECKS/CLEARANCES

SALARY & BENEFITS

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.

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