IDE Manager (NCI)

Location
20817, Bethesda
Posted
Jun 13, 2018
Ref
655789
Discipline
Clinical, Clinical Data
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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.  CMRP’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 supports the mission of the Cardiovascular Intervention Program within the Cardiovascular Branch of the NHLBI Division of Intramural Research for development of new catheter-based treatments for cardiovascular disease in adults and children for testing in a pre-clinical setting and clinically at collaborating medical centers.

KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL

  • Responsible for protocol navigation, including all aspects of protocol life-cycle requirements, managing a portfolio of clinical trials, and providing regulatory support for the Cardiovascular Intervention Program
  • Tracks the review process for all protocols and maintains detailed, complete and accurate records of approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions to IRBs and FDA such as adverse events
  • Facilitates the writing and regulatory review of study documents with bi-directional dialogue and feedback
  • Collaborates with investigators and study team members to create new protocols, independently writes/edits protocol and patient consent sections, including formatting and adding administrative language
  • Facilitates the process to obtain required approvals and tracks the required approvals necessary to initiate intramural research
  • Coordinates with investigators and study team members to ensure stipulations from approving bodies (scientific review, Institutional Review Board [IRB], regulatory agencies and radiation safety) are addressed appropriately and in a timely manner
  • Provides regulatory guidance to clinical investigators and other clinical staff
  • Coordinates activities pertaining to the compilation and submission of original IDE applications for management and multi-disciplinary team review and assists the research study team with Investigational Device Exemption (IDE) development and submissions to the U.S. Food and Drug Administration (FDA)
  • Responsible for the preparation, review, and submission of IDE applications to the FDA, as described in, 21 CFR 812, and particularly to the Center for Devices and Radiological Health (CDRH)
  • Submits IDEs, knowledge with IDE preparation and e-copy program or the electronic Common Technical Document (eCTD) format, as applicable
  • Requests, compiles, and reviews documentation for IDE amendments, annual reports, safety reports, unanticipated adverse device effect reports, and other submissions required for life-cycle maintenance of these applications
  • Assists study teams with preparation for FDA audits, by ensuring documents are organized and filed appropriately and that the Investigator and Sponsor’s regulatory binder is complete in compliance with FDA requirements.
  • Facilitates establishment of Clinical Trials Agreements (CTA) and Material Transfer Agreements (MTAs) with the Office of Technology Transfer and Development when applicable
  • Researches reports, regulations, guidelines, databases, internal policies in response to regulatory inquiries from internal and external sources
  • Interacts with regulatory agencies and other stakeholders
  • Participates in the review and revision of Standard Operating Procedures (SOPs) to adhere to FDA regulations and guidelines for Good Clinical Practices (GCPs)
  • Serves as a liaison for investigators and other clinical regulatory staff providing regulatory guidance, review and expertise to ensure documentation conforms to applicable regulations and guidelines
  • Collaborates with investigators to create concept documents and/or Letters of Intent (LOI)

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 health/scientific, or medical related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of eight (8) years of relevant experience
  • Regulatory experience with cardiovascular device studies requiring FDA Investigational Device Exemption (IDE), including application, reporting, audit, and compliance
  • Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups
  • Possesses demonstrated knowledge of clinical trial concepts, practices and project implementation, with an understanding of project management, data collection/requirements, regulatory and quality assurance procedures and ICH guidelines
  • Ability to communicate effectively, orally and in writing, with both non-technical and technical staff
  • Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects
  • Must be well versed in FDA regulations, 21 CFR, and GCPs
  • Must be proficient in all functions of clinical research implementation processes and conduct 
  • Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services [DHHS] regulations) 
  • Familiarity with protocol and informed consent documents and approvals needed to initiate a study 
  • Ability to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities 
  • Proficiency in Microsoft Office applications 
  • General knowledge of clinical research concepts, practices, and project implementation, with an understanding of project management and quality assurance procedures
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Master’s degree and RAC certification
  • Knowledge with e program or eCTD preparation and submission experience
  • Prior experience in adult and pediatric clinical trials management
  • Ability to operate word processing and spreadsheet applications independently with accuracy and speed
  • General knowledge of biological principles and scientific methods