Research Project Manager Regulatory – Beat Childhood Cancer Research Consortium

Penn State University•Tallahassee, FL

5d•$81,312 - $122,016•Remote

About The Position

The Beat Childhood Cancer (BCC) Research Consortium at Penn State College of Medicine is hiring a full-time Clinical Trial Regulatory Project Manager. BCC is an international clinical research sponsor and acts as a Contract Research Organization for a network of more than 54 hospitals across the United States, Canada, and Spain. The role supports research across more than 55 hospital sites and more than 10 clinical trials, with a specialized focus on regulatory compliance, study start-up, and regulatory document collection and maintenance. The position develops and administers BCC’s regulatory compliance program, oversees regulatory operations across the clinical trial lifecycle, and organizes compliance risk identification, inspections, and reporting. It develops and implements preventative measures and internal controls, supports regulatory documentation management, and maintains the Florence eBinder TMF/ISF system. This is a remote position with some required travel, up to quarterly and likely bi-annually. The position is funded for one year; continuation beyond that period depends on university need, performance, and/or funding availability.

Requirements

Master’s degree and at least 6 years of relevant experience, or an equivalent combination of education and experience.
Strong verbal and written communication skills.
Excellent organizational skills and ability to multitask.
Ability to work collaboratively and foster teamwork.
Ability to adapt to changing circumstances and work in a fast-paced environment.
Must be authorized to work in the United States; Penn State does not sponsor or take over sponsorship of staff employment visas.
Successful completion of required background checks.

Nice To Haves

Experience with central and institutional review boards (cIRB/IRB), Good Clinical Practice, and FDA IND requirements.
Experience working with teams, multiple Principal Investigators, and Phase I/II clinical trial projects.

Responsibilities

Develop and administer the BCC regulatory compliance program, providing guidance and oversight for regulatory documentation and processes.
Oversee sponsor-level regulatory responsibilities for study start-up, the trial lifecycle, and study closeout; maintain Florence eBinder TMF/ISF management.
Develop, administer, analyze, and implement compliance programs, including action plans based on the needs of the consortium and its sites.
Interpret and stay current on federal and state regulations applicable to BCC, including FDA, GCP, ICH, statutory, and regulatory requirements.
Maintain compliance with Good Clinical Practice guidelines and applicable regulations throughout the trial lifecycle.
Guide and train others in routine activities and functions, and serve as a liaison between senior BCC management, sites, and employees on regulatory compliance.
Advise study teams and investigators on regulatory study-related inquiries and issues.
Direct and oversee internal and external audits, 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; evaluate and resolve issues as they arise.
Develop and implement guidelines and procedures to streamline office operations.
Adapt to changing circumstances and work effectively in a fast-paced environment while managing multiple tasks and communicating clearly.