Penn State University · 2 days ago
Research Project Manager Regulatory – Beat Childhood Cancer Research Consortium
Hershey, PA
Full-time
Hybrid
Mid, Senior Level
$68K/yr - $115K/yr
3+ years expPenn State University is hiring a full-time Clinical Trial Regulatory Project Manager for the Beat Childhood Cancer Research Consortium. This position supports clinical trial research across multiple hospital sites with a focus on regulatory compliance and study-start up activities.
Higher Education
No H1B
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
Qualification
Required
Master's Degree
6+ years of relevant experience; or an equivalent combination of education and experience accepted (if filled as Research Project Manager - Senior Professional)
3+ years of relevant experience; or an equivalent combination of education and experience accepted (if filled as Research Project Manager - Advanced Professional)
Strong background in experience working with central and Institutional Review Boards (cIRB/IRB), GCP, and FDA IND requirements
Experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects
Strong verbal and written communication skills
Ability to multi-task while fostering an environment of collaboration and teamwork
Flexibility to adapt to changing circumstances
Ability to work in a fast-paced environment
Excellent organizational skills, multitasking and communication both written and spoken
Successful completion of background check(s) in accordance with University policies
Authorized to work in the U.S
Benefits
Comprehensive medical, dental, and vision coverage
Robust retirement plans
Substantial paid time off which includes holidays, vacation and sick time
Generous 75% tuition discount, available to employees as well as eligible spouses and children
Company
Penn State University
There’s a reason Penn State consistently ranks among the top one percent of the world’s universities.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Hamza Jamjoom
Co-Founder - Arts & Architecture Student Council
Kara Pytko
Co-founder of Virtual Scientist Webinar Series
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