Protocol Coordinator II - clinical trials
clinical trials, writing/editing, protocol development
The Clinical Monitoring Research Program (CMRP) 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.
Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials.This position will focus on responsibilities and requirements for submission of clinical protocols and other required documents/components to the FDA for CCR-held investigational new drug (IND)/investigational device exemption (IDE) applications.
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.
Coordinates submission of protocols for 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.
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.
Formats protocols and manages requirements for electronic submission of documents to FDA per electronic common technical document (eCTD) criteria.
Maintains the PDF version of the most current approved version of each active clinical protocol on a central server.
The Center for Cancer Research (CCR) is working to solve the most pressing problems in the field through basic, translational and clinical cancer research to create the cancer medicines of tomorrow and is dedicated to preparing the next generation of cancer researchers. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.
Our scientists can’t do it alone. It takes a skilled, multi-disciplinary team of dedicated staff in research, patient care and administration to improve the lives of cancer patients and answer the most important questions in cancer biology and treatment. Be part of our mission to unlock the mysteries of cancer through research to create the medicines of tomorrow.
We are the NCI’s internal, federally funded cancer center where world leading physician-scientists are working on the cutting edge of medicine developing clinical trials of new, sometimes “first-in-human” drugs and new treatment approaches. Closely knit clinical support teams are providing excellent quality of care of our patients and carrying out our clinical protocols with professionalism and compassion at the world’s largest dedicated research hospital on the NIH campus in Bethesda, Maryland. Join our unique and rewarding clinical team.
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.
Knowledge of clinical data report preparation.
Proficiency with Microsoft software applications.
Bethesda, located adjacent to Washington, D.C., is an urban core of Montgomery County, MD. Bethesda is one of the most affluent and highly educated communities in the United States. Living in Bethesda offers residents a suburban feel with a lot of restaurants, coffee shops, and parks. The public schools in Bethesda are highly rated.
“Please reference job id req751 for all inquiries.”
HHS, NIH, and NCI are Equal Opportunity Employers