Research Project Manager Regulatory – Beat Childhood Cancer Research Consortium

Penn State University • New York, NY

4d • Remote

About The Position

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 54+ 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)

Requirements

• The ideal candidate will have a strong background in experience working with central and Institutional Review Boards (cIRB/IRB), GCP, and FDA IND requirements.
• It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects.
• The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork.
• Master's Degree
• 6+ years of relevant experience; or an equivalent combination of education and experience accepted
• Master's Degree
• 3+ years of relevant experience; or an equivalent combination of education and experience accepted

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.

Benefits

• Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being.
• In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time.
• One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees