Clinical Research Associate I (req2187)

Posted: 10/12/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2187

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 to 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.

KEY ROLES/RESPONSIBILITIES

  • Works primarily in an in-house position
  • Assists with the implementation of clinical trials for the NCI DCP Coordinating Center sites, tracking studies and subject information, and coordinating project activities associated with the monitoring/auditing functions of clinical studies
  • Assists with the review of protocols, informed consents, and study related documents and tracking reviews
  • Reviews, 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 with review and development of reports/templates/case report forms/process documents
  • Provide support for the implementation and day to day file structure, tracking and logging key documents from site in support of the central coordinating center, including review of SOPs, processes, and guidance documents
  • Provide support to the core staff of the coordinating center and selected clinical research sites
  • Prepares progress and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness
  • Assists in compiling regulatory filing documents and maintaining computerized files to support all documentation systems
  • Maintains documentation file and archives related to the work scope for the customer
  • Assists in maintaining Documentation File inspection readiness by performing periodic review of the files for ICH GCP/ FDA compliance as requested (Stamps, tracks and files documents in accordance with SOPs and creates folders for the MDF)
  • 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 the CRAs, CTM III and other project managers with clinical site management, monitoring, auditing and regulatory activities in order to establish the coordinating center
  • Assists with investigator site activities in adherence to all applicable guidelines, including GCPs and SOPs
  • Assists with tracking clinical trials monitoring progress
  • Participates in and helps organize clinical trial activities with customer/sites, such as investigator meetings, study initiation, ongoing monitoring, and close-out visit activities when applicable
  • Serves as liaison between clinical research sites/vendors/other stakeholders
  • Assists in preparation and production of documents for Food and Drug Administration (FDA) submission, as well as annual IND protocol reports as applicable
  • May assist in the conduct of site monitoring/audit visits and initiate draft reports and letters in a timely manner to ensure compliance with processes
  • Performs other document processing and control functions as necessary to support business operations
  • Provides status updates to management (as needed) on a regular basis
  • Organizes/archives the shared network drive files
  • Performs other related duties as assigned by a responsible authority
  • May require travel 5-10%
  • 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 Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • No experience required beyond a Bachelor's degree
  • 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:

  • Two (2) years of related experience
  • Familiarity with FDA regulatory requirements and guidelines for clinical research, as well as quality assurance auditing/monitoring requirements
  • Infectious disease and/or oncology experience
  • Strong communication and presentation skills
  • Ability to think critically and focus on details
  • Knowledge of Department of Health and Human Services regulations
  • Experience with electronic regulatory sponsor and site study files
  • Experience in computer software packages including Microsoft applications
  • Spanish or Portuguese speaking
  • Monitoring, quality assurance and quality control knowledge