Penn State University
Compliance Specialist - Cancer Institute
Penn State University, Hershey, Pennsylvania, United States, 17033
Compliance Specialist - Cancer Institute
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Compliance Specialist - Cancer Institute
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Penn State University 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, Cancer Institute in Hershey, PA is seeking a Compliance Specialist 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. 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. 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 Bachelor's Degree 1+ years of relevant experience; or an equivalent combination of education and experience accepted Required Certifications: None BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of background check(s) in accordance with University policies. 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 $56,200.00 - $81,500.00. Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. 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.
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Join to apply for the
Compliance Specialist - Cancer Institute
role at
Penn State University 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, Cancer Institute in Hershey, PA is seeking a Compliance Specialist 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. 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. 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 Bachelor's Degree 1+ years of relevant experience; or an equivalent combination of education and experience accepted Required Certifications: None BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of background check(s) in accordance with University policies. 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 $56,200.00 - $81,500.00. Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. 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.
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