We are seeking a Clinical Research Program Manager/Clinical Research Supervisor to join the Southern California Lung Cancer Program (STELLAR) at VA Long Healthcare System, Research Service. As a PM, you will supervise the day-to-day activities of Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs to ensure efficient and effective initiation and operations of the Lung Cancer Research Program. You will be responsible for the start up and running of the new STELLAR Clinical Trials Program, in close partnership with other programs at the VA Long Beach Healthcare System, including but not limited to the Network of Dedicated Enrollment Sites, (NODES), the national VA Lung Cancer Precision Oncology Program (LPOP), National Cancer Institute (NCI), Department of Defense (DoD, various pharmaceutical companies, VA Office of Research and Development (ORD), Clinical Research Coordinators at the local and other sites, the Research Compliance Officer, and Institutional Review Board (IRBs) at the local and participating sites, and VA central and NCI IRBs. You will be responsible for data management activities and for data integrity associated with clinical trials research. You will participate in special projects and task forces as determined by management. You will manage several research protocols, including investigator initiative trials, industry-sponsored studies, as well as bio-specimen protocols. We are looking for a dedicated, collaborative clinical research professional to take on this leadership role. This is an exciting opportunity to join a growing clinical research team.
Be an experienced clinical trials manager with extensive knowledge as a lead
clinical research coordinator (CRC) and PM. The position requires extensive knowledge in managing all phases of clinical trials. The position possesses in-depth knowledge of regulatory, patient recruitment and budgetary aspects of clinical trials.
Staff Management and Development - Participate in the orientation, training and supervision of CRCs/CRAs; participate in facilitating departmental trainings; align staff and resources with appropriate protocols and research needs; and maintain workflow consistency among staff with standardized processes.
Operation Management - Ensure that workflow is managed and monitored to meet departmental and service needs; oversee protocol activation, especially with start-up activities; monitor research portfolio for workload by appropriately managing and identifying service needs.
Quality Assurance - Perform regular audits to ensure that the data collected is complete and accurate, and that the research project is carried out as planned.
Regulatory Compliance - Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Also, you will ensure that research protocols are approved by the Institutional Review Board/Privacy Board (IRB/PB) and followed as written.
Special Projects - Participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested. You will provide leadership, organizational, creative, or clerical support to established and new research initiatives. Provide leadership and oversight to regional participating sites.
Lead and liaise meetings with a variety of stakeholders across multiples disciplines.
Serve as key team member, providing supervision to staff, support Principal Investigator and clinicians on a daily basis.
Effective at building formal and informal networks inside and outside the organization to further departmental and institutional goals.
Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.
A good decision-maker, with shown success at making timely decisions that keep the organization moving forward.
Eager to foster talent and support people in meeting their career goals and the organization's goals.
At least 3 years of clinical research experience.
Earned a Master’s degree in a related field
Supervisory experience and experience with high volume clinical trials
Comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA) is critical.
Strong time management/project management skills.
Experience working with a project submission platform
Knowledge of oncology-specific terminology is helpful.
Experience in the use of various electronic data management systems.
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