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JOB DESCRIPTION AND POSITION REQUIREMENTS: The Penn State College of Medicine (COM), Department of Public Health Sciences (DPHS), in Hershey, PA, is seeking a Research Compliance Assistant to support the Data Coordinating and Clinical Trail Monitoring functions of the DPHS. The Research Compliance Assistant will be responsible for supporting data management activities and administrative processes through source data verification, source document review, compliance audits and investigations, responding to or directing inquiries; managing file maintenance, storage, security; attending meetings; and assisting with training. The Compliance Assistant will work on clinical studies in different therapeutic indications, to ensure the highest quality standards are maintained and that all research being conducted is regulated and meets all applicable standards and policies.

RESPONSIBILITIES Conduct supporting data management and administrative tasks such as regulatory document review, source data verification, source data review, laboratory documentation and biospecimen review, drug accountability and compliance review, device accountability, and query resolution. Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies, and standard operating procedures. Adhere to approved research protocol and clinical trial monitoring plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring checklists and related tools/templates. Collect, organize, and review compliance requirement documentation; conduct investigations; as instructed, report findings to appropriate management, compliance committees, administration, federal agencies, etc.; remediate issues and monitor compliance. Monitor clinical trial progress through a combination of data review and on-site and/or remote monitoring visits for single and multisite studies, as instructed. Meet expected timelines for completion of monitoring activities and submission of written monitoring reports. Report to the Unit Manager, clinical trial monitoring and data management Project Leader(s), COM IRB, and/or COM Research Quality Assurance Office on monitoring visit findings, if applicable. Participate in regular department and team meetings.

This is a limited-term position funded for one year from date of hire, withpossibility of refunding.

REQUIREMENTS Location: Ability to work on-site and/or remotely as needed. Minimum Education: High School Diploma/GED or Vocational Training/Degree Minimum Experience: 2+ years of relevant experience Equivalency: An equivalent combination of education and experience.

The following clearances must be successfully completed for this position: Pennsylvania State Police Criminal Background Check Pennsylvania Child Abuse History Federal Bureau of Investigation (FBI) Criminal Background Check

The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion inall ofits forms.We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive exce lence as a core strength and an essential element of our public service mission.

The salary range for this position, including all possible grades is: $38,300.00 - $55,500.00

Salary Structure - additional information on Penn State's job and salary structure.

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.

Employment with the University will require successful completion of background check(s) in accordance with University policies.

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Penn State is an equal opportunity, affirmative action 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.