Regulatory Submission Coordinator
December 18, 2022
Regulatory Submission Coordinator
Job ID: req2506
Employee Type: nonexempt 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., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program'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
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Job ID: req2506
Employee Type: nonexempt 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., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program'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
- Performs regulatory submission/administrative duties for the Protocol Support Office, NCI/CCR
- Assists with the preparation and filing of documents to include protocols, consent forms investigator brochures, safety reports, and regulatory documents
- Provides accurate filing of pertinent regulatory documents
- Provides administrative support related to document control requirements including filing of master documents, formatting and typing of various documents
- Manages external collaborator site/investigator registration systems and documents (e.g., CTEP registration/RCR dashboard)
- Manages communication with external collaborators/sponsors, as assigned (e.g., monthly, and quarterly accrual reports)
- Orders office supplies
- Maintains inventory of office equipment
- Attends regulatory and administrative meetings for taking and typing of minutes, reports, and summaries
- Communicates with clinical, administrative and management personnel to gather or convey information
- Edits and prepares material for final review, including email correspondence
- Updates internal tracking metrics, information, and webpages (e.g., CCR Wiki page)
- Participates in planning functions
- Works in conjunction with other administrative staff to accomplish program requirements
- Acts as liaison coordinating tasks/deadlines between the PSO and the Branch/teams
- This position is located in Rockville, Maryland
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a high school diploma or equivalent
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to education requirement, a minimum of three (3) years of progressively responsible administrative experience
- Ability to work in a clinical research setting, both independently and within a team
- Ability to compile and maintain regulatory files
- Working knowledge of FDA regulations for Good Clinical Practices (GCP)
- Ability to prioritize multiple tasks/projects through effective organizational and planning skills
- Proficiency in Microsoft software applications (Windows, Word, Excel, and PowerPoint)
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- College degree
- Experience in medical/scientific setting
- Knowledge of medical terminology and regulatory guidelines
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork