Senior Regulatory Submissions Coordinator (Lutherville Timonium)

Frederick National Laboratory for Cancer Research in Lutherville Timonium, MD

  • Industry: Advertising/Marketing/Public Relations - Event Coordinator/Planner
  • Type: Full Time
  • $56,240.00 - 91,780.00
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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 comprehensive clinical and administrative support to the National Cancer Institute's Center for Cancer Research's (CCR) Office of the Clinical Director for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration.

KEY ROLES/RESPONSIBILITIES
  • Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials
  • Provides deployment of clinical support services for clinical research
  • Streamlines protocol development timeline
  • Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities
  • Provides technical review and report preparation
  • Provides administrative coordination and general logistical support for regulatory activities
  • Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture
  • Provides quality assurance and quality control oversight
  • Performs regulatory review of clinical protocols, informed consent and other clinical documents
  • Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services)
  • Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms
  • Prepares protocol packages for review and ensures that protocol packages include all the required material and comply with CCR, NCI and NIH policies
  • Collaborates with investigators to resolve any protocol/data issues
  • Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA
  • Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events
  • Attends and prepares minutes for the Branch Protocol Review Committees
  • For protocols that are performed with other research centers:
    • contacts coordinators at other centers to obtain review committee approvals at these centers,
    • maintains records of these approvals at the outside centers in the protocol files, and
    • sends protocol amendments and other reports to the participating centers
  • Maintains a schedule of all review committee submission deadline dates and meeting dates
  • Assists clinical investigators in understanding and complying with the entire review process
  • Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols
  • Converts protocols from word format to PDF with bookmarks
  • Maintains the PDF version of the most current approved version of each active clinical protocol on a central server
  • This position is located in Rockville, Maryland or Frederick, Maryland

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of six (6) years progressively responsible clinical trial protocol development and management experience
  • Ability to serve as a liaison with various NCI staff and Principal Investigators to initiate and complete tasks relating to oncology clinical protocols
  • Ability to interpret International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines
  • Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials
  • Advance knowledge and skill of the tracking system functions for NCI protocols and provide reports to clinical investigators and the Branch Chiefs
  • Advance knowledge of formatting word documents
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Knowledge of clinical data report preparation
  • Proficiency with Microsoft software applications
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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