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JOB DESCRIPTION AND POSITION REQUIREMENTS
Position Specifics: Penn State College of Medicine is seeking an experienced professional to join the Children’s Oncology Group, in the department of Pediatric Hematology/Oncology, to assist with a multi-phase preparation effort for a scheduled audit. COG audits are comprehensive evaluations conducted to assess compliance with federal regulations, GCP (Good Clinical Practice), NCI/NIH guidelines, and internal protocol standards.
Ideal candidates will have experience in conducting human subjects clinical research. Their responsibilities will include:
- Informed Consent Verification:
Ensuring that all consent forms are properly documented, signed, and dated according to protocol requirements, with appropriate version control and compliance with federal and institutional policies. - Eligibility Verification & Protocol Adherence:
Confirming that patient eligibility was appropriately assessed and documented at enrollment, and that all study procedures and follow-ups align with the protocol. - Data Quality and Case Report Form (CRF) Reconciliation:
Reviewing CRFs and source documentation to resolve any discrepancies, ensure data integrity, and confirm consistency across systems (e.g., EDC, EMR, source notes). - Deviation & SAE Documentation:
Reviewing all protocol deviations and serious adverse events (SAEs) to ensure proper reporting timelines, documentation, and resolutions are in place. - Coordination with Multidisciplinary Teams:
Collaborating with regulatory specialists, investigators, data managers, and pharmacy staff to proactively identify and address gaps ahead of the audit.
BACKGROUND CHECKS/CLEARANCES
Employment with the University will require successful completion of background check(s) in accordance with University policies.
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.
The Pennsylvania State University is committed to and accountable for advancing equity, respect, and belonging in all its forms. We embrace individual uniqueness, as well as a culture of belonging that supports both broad and specific 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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