Associate Clinical Trials Manager

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

KEY ROLES/RESPONSIBILITIES

The Clinical Monitoring Research Program Directorate (CMRPD) provides essential program/project management expertise to support the National Institute of Mental Health (NIMH).

• Provides support in strengthening the infrastructure for successful clinical research on behalf of the Office of the Clinical Director (OCD) for trials that range from non-invasive minimal risk protocols to phase 0 -IV clinical trials
• Coordinates the implementation of new protocols including working with Clinical Trials Database (CTDB) to design platforms for mandatory data collection of common data elements
• Helps to ensure compliance with FDA regulations, NIH policies related to data management and protocol compliance
• Performs study initiation, ongoing monitoring, and close-out visits as needed
• Ensures appropriate reporting of Adverse Events and Serious Adverse Events and other reportable events, tracks subject information, verifies randomization, drug dispensing and accountability
• Works together with investigators and Clinical Research Associates (CRAs) to establish clinical monitoring plans
• Oversees the conduct of a CRA in performing various types of study visits
• Assists in managing the review and approval of monitoring reports from CRAs prior to and upon completion
• Outlines training needs for investigators, research nurses, and research staff, and assists with training as applicable
• Provides guidance and mentoring in support of the NIMH in regard to SOPs, GCPs, FDA and International Conference Harmonization (ICH) regulations governing clinical trials, daily activities and data entry related systems
• Provides QA and QC oversight of clinical trials, to include: coordinating GCP monitoring of non-Investigational New Drug (IND) and IND protocols domestically; general QA for data; and the development and maintenance of progress reports, updates, databases (Access/CTDB) and tracking essential study documents and data for reports
• Assists in developing, reviewing, and preparation of reports (including NIMH metrics, CMRP internal annual program reports), letters, templates, monitoring plans, Case Report Forms, and Corrective and Preventive Action (CAPA) plans
• Provides training and mentoring for team members with regard to monitoring processes for CTM, SOPs, GCPs, regulations, and daily activities
• Presents information to internal and external customers though PowerPoint presentations, webinars, or live training sessions, as needed
• Additional responsibilities as assigned based on program need
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biology, clinical research, project management or related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the educational requirements, a minimum of four (4) years of progressively responsible experience in a clinical trials/research and/or project management environment, including a minimum of two (2) years of directly related to overseeing multiple concurrent protocols
• Onsite monitoring experience for IND and/or Investigational Device Exemption (IDE) studies
• Ability to work in a busy clinical research management setting, both independently and within a team
• Excellent oral and medical/technical writing skills
• Proficiency in Microsoft Office Suite including Project, Access, Visio, and PowerPoint
• Ability to communicate effectively with program leaders
• Strong interpersonal, leadership, and analytical skills
• Ability to demonstrate good judgement and decision making, attention to detail, and personal accountability
• Ability to effectively handle multiple tasks and priorities
• Ability to create and maintain a full spectrum of clinical trials program/project management documents
• Thorough understanding of the clinical research environment
• Ability to maintain a collaborative working relationship with site PIs, study staff and Clinical Research Organizations (CROs)/outside monitors
• Supervisory experience
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Master's degree
• Knowledge of clinical trial fieldwork monitoring concepts and practices including on site monitoring requirements, FDA and IND regulations, and GCPs
• Knowledge of conducting federally funded studies
• Certified clinical research professional (CCRP)
• Familiarity with regulatory requirements and guidelines for facilitating clinical human subjects research
• Knowledge of Data Management Systems
• Knowledge of QA/QC processes
• Certified Project Management Professional (PMP)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)