Clinical Regulatory Affairs Specialist (Part-time
Required DoD Security Clearance:
Positions may require U.S. citizenship for purposes of obtaining clearances.
Additional clearances may also be required from the DoD.
Expected Job Duties:
Review and provide subject matter expert assessment of regulatory submissions with particular input regarding clinical study aspects of contracted activity, to assist in identifying deficiencies or problems regarding clinical issues prior to submission to the FDA.
Specific the Specialist would:
Ability to attend meetings involving the described subject matter and prepare records of questions a comments relative to proceedings.
Ability to review and assess product development related documentation, presentations and meeting proceedings to provide regulatory issue input during the product development process with emphasis on clinical study-related activities of BARDA contracted work.
Provide clinical study subject matter expert advice and guidance for regulatory and/or quality assurance issues involving contracted countermeasure sponsor and/or for FDA, CDC, NIH and DoD/BARDA cooperative projects.
Ability to interface with the relevant FDA Centers regarding clinical studies aspects of regulatory and/or quality assurance issues associated with the product development throughout the investigational, advanced development, approval and post-marketing phases of countermeasure development.
Ability to conduct site visits and/or study audits as needed, in accordance with FDA regulations and FAR/HHSA regulations pertaining particularly to aspects of product clinical development, including but not limited to clinical study planning, design, execution and reporting.
Possession of appropriate skills and knowledge to execute the referenced site visits or audits.
Ability to conduct pre-award, pre-operational, annual and/or for-cause site visits or audits for the referenced work.
Possession of appropriate training, and certifications for performance of the described work, including a Medical Doctor (MD) degree, from an accredited US medical college or have passed an appropriate foreign graduate examination and hold a license to practice medicine in at least one state in the US.
Possession of significant experience performing the described work comprising a minimum of 5 years of experience, 3 of which should have been in FDA-regulated drug and/or biologics industry.
Possession appropriate experience developing clinical studies and experience as a clinical study principal investigator (PI) is preferred.
Grove Resource Solutions, Inc.
Phone: 301-668-6202 opt 3
GRSi is a woman-owned, small business that offers diverse engineering and technology resources to government, military, and high-tech clients. Attentive management and dedicated people have earned GRSi a reputation for high performance on strategic government contracts.