Job Description Project Coordinator, Protocol Development (Oncology) Location: Boston, Massachusetts Date Posted: 7/28/2022 Employment Type: Permanent Recruiter: Mohamed Barami Recruiter Email: mo.barami@avidtr.com Job ID: JN -072022-15163 Job Description Project Coordinator, Protocol Development (Oncology)The Project Coordinator is responsible for managing all aspects of the protocol development process for a specific disease site or subset of disease sites.Responsibilities: Responsible for the oversight and management for all protocol development functions across all disease sites – NCTN and NCORPSupervises and monitors staffParticipates in training of new staff and assists in the development of relevant training programs and other presentationsDevelops SOPs and study documentation as needed and distributes studies for reviewCoordinates reviewer input and incorporates consensus changes into protocolsWorks to support protocol development staff in their interactions with study chairs and co-chairs, statisticians, data associates, the NCI, and field reviewers throughout all phases of the protocol development processAssist in the development and implementation of quality control procedures.Conducts quality control reviews of protocols and related documents for scientific and editorial accuracyAssists staff with troubleshooting problem studies, identifying issues and resolving problems in a timely wayAssumes a leadership role within the Protocol Development departmentManages and conducts the weekly Protocol Development POD meetings Conducts final review of protocols prior to major review and NCI submissionParticipates in the hiring and interviewing of potential new employeesAssumes responsibility for multiple special projects, as assigned by the Senior Director Experience A minimum of three (3) years of experience working in a clinical research setting, and oncology experience a plusA minimum of three (3) years management/supervisory experienceStrong computer skills with proficiency with MS Office and other related systems applicationsKnowledge of Good Clinical Practices (GCP) and understanding of ICH/FDA guidance for Good Clinical Practice (GCP)Experience or education in medical or scientific area an advantage, particularly oncology Education Bachelor's degree from an accredited college or university and/or relevant professional experience is required Apply for this job