Protocol Coordinator II/III - Regulatory Submissions (NCI/NIH) - HYBRID/REMOTE

Job ID: req3539
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) Protocol Support Office (PSO) 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

• Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services)
• Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms
• Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies
• Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA
• 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
• Provides data and documents collection and compilation for regulatory filing with the Food and Drug Administration (FDA) and other regulatory authorities
• Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture
• Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent, and other clinical documents
• Collaborates with investigators to resolve any protocol/data issues
• Provides technical review and report preparation
• Streamlines the protocol development timeline
• 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
• Attends and prepares minutes for the Branch Protocol Review Committees
• Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals 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 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 hybrid, with minimal travel to the office required. Office is located in Rockville, Maryland
• Out of area candidates will be considered

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
  
  • Protocol Coordinator II - In addition to educational requirements, a minimum of two (2) years progressively responsible clinical trial regulatory documents development, submission and management experience
  • Protocol Coordinator III – In addition to educational requirements, a minimum of five (5) years progressively responsible clinical trial regulatory documents development, submission 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
• 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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