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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 .
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.
POSITION SPECIFICS
The Beat Childhood Cancer (BCC) Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Regulatory Project Manager. The Beat Childhood Cancer Research Consortium is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 54+ hospitals across the US, Canada, and Spain that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 55+ hospital sites on 10+ clinical trials and has a specialized focus on regulatory compliance, study-start up activities, and regulatory document collection and maintenance. This position will organize and conduct compliance risk identification, inspection, and reporting; develop and implement preventative measures and internal controls as well as oversee the day-to-day regulatory operations for our team.
For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org)
Job Duties & Responsibilities:
Develop and administer regulatory compliance program for the Beat Childhood Cancer Research Consortium (BCC). Provide guidance and oversight for regulatory documentation maintenance and management of regulatory processes.
Oversee Study Start-up, Trial Life-cycle, and Study Closeout at the Sponsor Level regulatory responsibilities and maintain Florence eBinder TMF/ISF management.
Develop and administer compliance programs with continuous analysis, interpretation, resolution and implementation of programs and implement appropriate action plans and execute based on the needs of the consortium and their 54+ sites.
Interpret and be up to date on federal and state regulations concerning BCC’s regulatory compliance program, including but not limited to FDA, GCP, ICH, statutory, and regulatory compliance requirement changes.
Maintain compliance with Good Clinical Practice (GCP) guidelines and applicable regulations throughout the trial life cycle.
Guide and train others in routine activities and functions while serving as a liaison between senior BCC management and BCC sites and employees related to regulatory compliance.
Serve as a resource for study teams and investigators regarding regulatory study-related inquiries and issues.
Direct, manage, and oversee internal audits, external audit, pre-inspections, and audits responding to non-compliance reports at the executive level.
Develop relationships with BCC and University staff, research collaborators, other BCC institutions, and regulators as necessary and in the best interests of the program. Teammate will evaluate and resolve issues or problems as they arise.
Develop and implement new guidelines and procedures that will streamline the office operations.
Flexibility to adapt to changing circumstances.
Ability to work in a fast-paced environment.
Excellent organizational skills, multitasking and communication both written and spoken.
The ideal candidate will have a strong background in experience working with central and Institutional…