Regulatory Submissions Coordinator
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Rockville, MD, USA
- Start date
- Nov 1, 2019
View more
- Discipline
- Clinical, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
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.
KEY ROLES/RESPONSIBILITIES
- Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials
- 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
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
- Advanced knowledge and skill of the tracking system functions for NCI protocols and provide reports to clinical investigators and the Branch Chiefs
- Advanced 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
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert