Regulatory Manager - Beat Childhood Cancer Research Consortium

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POSITION SPECIFICS

The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Regulatory Manager. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 50+ 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 52 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 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. This is a remote position with some required travel (up to quarterly; likely bi-annual) per year. This position is expected to have one direct report.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

BACKGROUND CHECKS/CLEARANCES

SALARY & BENEFITS

Salary Structure - Information on Penn State's salary structure

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. For more detailed information, please visit our Benefits Page.

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.

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