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Clinical Research Associate I - HYBRID

Job ID: req3872
Employee Type: exempt full-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 NIAID Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging and re-emerging infectious disease studies globally. The CMRPD, Clinical Trials Monitoring (CTM) Group, provides comprehensive clinical trials management and oversight support to the various clinical research initiatives of the NIAID, DCR.

KEY ROLES/RESPONSIBILITIES

• Works primarily in an in-house position
• Assists with the implementation of clinical trials, tracking studies and subject information, and coordinating project activities associated with the monitoring functions of clinical studies
• Assists with the review of protocols, informed consents, and study related documents
• Maintains and tracks regulatory files/essential Master Documentation Files (MDFs) while working closely with other team members to ensure these documents are properly managed and are current and accurate
• Assist in the collection, review and tracking of FDA Sponsor related paper and electronic trial master files (eTMF)
• Interacts and supports internal and external staff to facilitate meeting project timelines and tasks in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and all applicable regulatory guidelines
• Supports CRAs and project managers with clinical site startup and ongoing management activities
• Assists with managing the relationship between Clinical Research Organizations (CROs) and field CRAs, as needed
• Assists with investigator site activities in adherence to all applicable guidelines, including GCPs and SOPs
• Helps ensure appropriate reporting of Adverse Events (AEs), Serious Adverse Events (SAEs) and Unanticipated Problems (UPs)
• Assists with the review and possible design and production of subject Case Report Forms (CRFs)
• Assists with tracking clinical trials progress
• Participates in and helps organize clinical trial activities with CROs, such as investigator meetings, study initiation, ongoing monitoring and close-out visit activities when applicable
• Assists in preparation and production of documents for Food and Drug Administration (FDA) submission, as well as annual IND protocol reports
• May assist in the conduct of site visits and initiate draft reports and letters in a timely manner to ensure compliance with SOPs
• May require local travel 5-10%
• This is a hybrid position 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 Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• No additional work experience required beyond the degree requirement
• Ability to work in a clinical research setting both independently and within a team
• Ability to prioritize multiple tasks/projects through effective organization/planning skills
• General knowledge of clinical trial fieldwork concepts and practices, FDA regulations and GCPs
• Knowledge of database management
• Must be willing to travel approximately 5 -10% local/domestic
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Familiarity with FDA regulatory requirements and guidelines for clinical research, as well as monitoring requirements
• Experience with GCPs, FWAs, IRB procedures including central IRBs
• Infectious disease experience
• Strong communication and presentation skills
• Ability to think critically and focus on details
• Knowledge of Department of Health and Human Services (DHHS) regulations
• Experience with the development of CRFs, FrameMaker® and/or TrackWise®
• Experience with electronic regulatory sponsor and site study files, including various tracking software
• Experience in computer software packages including Microsoft applications
• Ability to read/understand French and/or Spanish
• Experience with remote review of regulatory files

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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