Breadcrumb

Protocol Coordinator - Clinical research, data/document collection

Date Posted
Position is with

Job Description

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical and administrative support to the NCI'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.

Protocol Coordinator I

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

Protocol Coordinator II

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 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

Qualifications and Job Details

Degree Required
B.S./B.A. or equivalent
Job Location
Frederick
Rockville
Appointment Type
Contractor Position (Salary commensurate with experience)
Work Schedule
Full-time
Citizenship
US Citizenship not required - (ie, permanent resident, visa)

Required and Preferred Skills

Required Skills

Protocol Coordinator I

  • 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 two (2) 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

Protocol Coordinator II

  • 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 five (5) 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 Skills
  • Knowledge of clinical data report preparation
  • Proficiency with Microsoft® software applications

About the NCI Center for Cancer Research

The Center for Cancer Research (CCR) is home to nearly 250 basic and clinical research groups located on two campuses just outside of Washington, D.C. CCR is part of the National Cancer Institute (NCI) and makes up the largest component of the research effort at the National Institutes of Health (NIH). Centrally supported by long-term funding and a culture of complete intellectual freedom, CCR scientists are able to pursue the most important and challenging problems in cancer research. We collaborate with academic and commercial partners and advocacy groups across the world in efforts to prevent, diagnose and treat cancer and HIV/AIDS. The CCR research portfolio covers the full spectrum of biological and biomedical research. Our work ranges from basic to translational and clinical, and our clinical trials are conducted in the NIH Clinical Center, the world’s largest hospital dedicated to clinical research that offers a robust infrastructure to support CCR’s patients on an estimated 250 open studies. The success of CCR is grounded in an exceptionally strong discovery research program that provides the foundation for the seamless translation of insights from bench to bedside. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.

Frederick

Frederick is the second largest city in Maryland but retains a “small town” feel, surrounded by mountain views with a vibrant Main Street community. The city offers outstanding schools, a balanced and thriving economy and a highly educated workforce.

Rockville

Rockville is one of Maryland’s oldest towns and one of America’s leading small cities for work, play and life. Adjacent to Washington, D.C., it is the vibrant, highly educated, business-friendly home to some of the nation’s and the world’s most prominent biomed and technology companies.

How to Apply
Submit:
  • CV/Resume
  • Three References
  • Cover Letter
Additional Application Information

How to Apply: https://leidosbiomed.csod.com/ats/careersite/jobdetails.aspx?site=4&c=leidosbiomed&id=572

Additional Information: Please reference job id req2525 for all inquiries.

Hiring for this position will be through Leidos Biomedical Research Inc., a wholly owned subsidiary of Leidos, Inc.  Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.

Contact Information
Contact Name
Lauri Rimorin
E-mail Address
Lauri.Rimorin@nih.gov
DHHS, NIH and NCI are equal opportunity employers. The NCI and CCR are deeply committed to diversity of thought, equity and inclusion and encourage applications from qualified women, underrepresented minorities and individuals with disabilities.