Protocol Coordinator I

Protocol Coordinator I

Job ID: req3137
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Rockville: Rockwall
Location: 11400 Rockville Pike, Rockville, MD 20892 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., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.  CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’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

• Assists with providing programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials
  
• Assists with 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 administrative coordination and general logistical support for regulatory activities
  
• 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
  
• Maintains a schedule of all review committee submission deadline dates and meeting dates
  
• 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
  
  

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 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
  
• No experience is required beyond a bachelor's degree
  
• 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
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• 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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