CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
CAMRIS is seeking a Clinical Advisor to support the mission of the National Institute of Allergy and Infectious Diseases (NIAID) at The National Institutes of Health (NIH) by conducting and supporting basic, translational and clinical research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.
*This position is contingent upon contract award.
* Provide operational support to Contracting Officer’s Representative (COR) for Division supported contracts providing clinical trial monitoring services in the context of domestic and international settings.
* Provide advice on clinical research operations, regulatory affairs, GCP, or other related clinical research issues such as:
a) review of site trend analyses or site monitoring reports;
b) identification of concerns and solutions to site performance issues; and
c) identifying opportunities for improving operations through site-specific training or site-specific visits
* Assist in the development of tools and processes that will improve the effectiveness and efficiency of clinical monitoring
* Develop Protocol Specific Monitoring Plans tailored to specific human subject protection and data integrity risks of the trial
* Shadow monitoring visits to sites as necessary to assess compliance and potential challenges
* May be responsible for oversight of a small portfolio of Clinical Research Sites (CRS) (Network and Non-Network). For these sites, serve as the day-to-day contact for CRS staff to facilitate clinical research site development, protocol implementation, and other operational and regulatory issues. Advise Principal Investigators on clinical site start-up issues including resource allocation, personnel management and administrative issues. Sites may be Network affiliated sites or investigator-initiated project (Non-network) sites.
* Direct and conduct formal evaluations of the CRS’s organizational structures and modes of operation in relationship to the achievement of the Division’s goals and objectives in the areas of administration, clinical site management and recruitment of participants.
* Provide oversight and technical direction for evaluation of site performance using data compiled by Network/Non-network data management centers and other DAIDS contractors.
* Assess the level of clinical research competency of CRSs and the extent of research knowledge and technology available to achieve the desired quality of operations at the clinical research sites.
* Attend Network meetings, conference calls, ad hoc meetings and working groups as needed.
* As needed, conduct trainings for sites and Network meeting participants on relevant policies and regulations.
* Assist with drafting and uploading reports to the OCSO SharePoint site (Portal).
* Interface with NIAID program staff and with the Clinical Site and Study Monitoring (CSSM) contractor to support regular meetings related to task coordination.
* Participate in working groups to provide technical expertise in development of new OCSO policies and standard operating procedures (SOPs).
* Review and participate in drafting new procedures and work instructions for monitoring contract services.
* Prepare oral and written presentations for internal and external programmatic and scientific meetings.
* Master’s degree in a related discipline.
* Three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
* Three (3) years of experience in the clinical research field.
* Ability to prepare oral and written presentations for internal and external programmatic and scientific meetings.