Clinical Trials Manager II

Job ID: req3593
Employee Type: exempt part-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

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.
The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Cancer Institute, Division of Cancer Prevention (DCP). CMRPD is responsible for providing clinical trial support services (setting up a coordinating center) to support NCI/DCP global clinical research studies. The CMRPD provides comprehensive clinical trials management and oversight support to the various clinical research initiatives of the NCI/DCP. This position may support various institutes of the NIH.
KEY ROLES/RESPONSIBILITIES

• Leads the implementation and oversee the day-to-day management of a clinical trial coordinating center, including, but not limited to, operational infrastructure, communication and quality management/monitoring plans, and work instructions and process flows
• Assists with the planning and implementation of clinical trials at selected clinical research sites
• Assists in the compilation of regulatory documentation (e.g., protocol, Investigator Brochures, ICF) for compliance with applicable regulations and pertinent guidance
• Supports the preparation, tracking, and submission, and maintenance of regulatory documents, filing amendments, and undertaking correspondence with regulatory authorities
• Supports the preparation of submissions to relevant Institutional Review Boards and regulatory oversight agencies
• Supports development of timelines for the drafting, review, and submission of regulatory information, and working with key contributors and regulatory production team to ensure timely compilation of reports and submissions and communication of status to project team and external stakeholders
• Reviews clinical trials documents and verification of data (via source data review) for study documents including (but not limited to) study protocol, Informed Consent Forms, patient information material, recruitment and retention information guides, and Case Report Forms
• Establishes productive working relationships with clinical trial sites
• Plans and directs the administrative and programmatic support for activities in order to effectively manage available resources (staffing, space, supplies, and office equipment)
• Monitors progress of clinical studies by analyzing progress reports such as monthly minimum dataset submissions (MDS), patient accrual reports, and other clinical trials monitoring activities performed by the coordinating center
• Ensures quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
• Develops and evaluates ongoing training programs and oversee the monitoring of the studies
• Serves as a liaison and resource for assigned clinical research sites as well as, serves as a liaison between various Leidos Biomed, NCI entities and collaborating offices, interacting with both scientific and administrative officials
• Undertakes and participates in site visits and facilitate follow up resolutions as needed to help perform risk based and centralized data review
• Ensures accuracy of clinical trial information in all clinical trial systems and databases, and tracking systems
• Analyzes audit findings, identifies, and reports trends, and makes improvement recommendations to management
• Coordinates efforts with sites and clinical data management as needed for data management systems for the study
• Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting, and evaluating the assigned program objectives
• Identifies and assesses clinical trial sites and the necessary infrastructure to carry out clinical studies domestically and internationally if needed, including clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support
• May assist in assessment of site preparedness and perform site qualification visits
• Provides mentoring, leadership, and supervision to other staff
• Travels up to 15%
• This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college/university according to (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of six (6) years of progressively responsible relevant experience in clinical research including a minimum of four (4) years directly managing multiple concurrent clinical trials
• Fluency in Spanish and/or Portuguese is required
• Clinical trial project management experience including experience as a Clinical Research Associate of Specialist
• Direct experience in auditing/monitoring clinical trials in diverse patient settings
• International clinical trials experience
• Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience
• Experience in preparing and managing site management plans
• Proficiency in all functions of clinical research implementation processes and conduct
• In-depth knowledge of the clinical trial and drug development process
• Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
• Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP), ICH, and relevant regulatory agency requirements domestically and internationally.
• Knowledge of clinical trial fieldwork concepts and practices
• Supervisor expertise
• Ability to travel domestic and internationally
• Strong skills in MS Word, Excel, and Outlook.
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Oncology clinical research experience
• Knowledge of Quality Assurance/Quality Control processes
• Knowledge of site selection activities and tracking site capabilities
• Organized, detail oriented, and have excellent written and oral communication skills
• Works independently functioning within a multidisciplinary team environment
• Excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
• Ability to prioritize effort across multiple projects and subject areas
• Experience working on NIH funded studies is a plus and of HHS regulations
• SoCRA or ACRP certification is a plus

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