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• If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants.

JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. 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 and has a specialized focus on research project operations including study methodologies, protocol development, logistical support, project management and timelines.

For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org)

Job Duties and Responsbilities:

Protocol Management

• Reviews and provides approval for the enrollment of study participants based on inclusion/exclusion criteria onto active BCC clinical trials from participating study sites.
• Oversees and advises on research projects from study initiation to conclusion including study design, data collection, management plans. Performing phase I and phase II protocol reviews to identify potential concerns and recommending improvements before release of protocol to the study sites.
• Designs and manages work-flow processes for required and supporting documents for study protocols to maintain data accuracy.
• Uses existing practices as a foundation to build upon to improve work-flow processes internally and externally for each protocol.
• Collaborates with internal team daily utilizing medical knowledge to review and ensure accuracy and safety in the protocol development, process of data collection and study design and oversight.
• Maintain up-to-date knowledge of and promote understanding and compliance with relevant laws and regulations.

Safety Monitoring and Management

• Oversees study data collection including quality assurance by querying and maintaining contact with study sites.
• Monitors and manages appropriate documentation internally and externally all Serious Adverse Events for all study sites required for FDA and other regulatory reporting.
• Author, review and revise standard operating procedures for maintenance of clinical research operations.