APPLICATION INSTRUCTIONS:

• CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday.

• CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.

• If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants.

 

Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants.

 

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 o