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Clinical Advisor IV-17227

Huntington Ingalls Industries - Technical Solutions Division, Integrated Mission Solutions Group (Camber Corporation) provides mission-critical engineering and technical service to Information Technology, Federal Civilian, and National Security, Aerospace & Defense and International government and commercial customers at over 100 locations worldwide.

HII-TSD, Integrated Mission Solutions Group (Camber Corporation) is currently seeking a Clinical Advisor IV to work on Ft.

Detrick.  

The following statements of duties and responsibilities are intended to describe the general nature and level of work being performed by individuals assigned to this position.

These statements are not intended to be an exhaustive list of all duties and responsibilities required of all personnel within this position.

Actual duties and responsibilities may vary depending upon assignments and other factors.

Duties and Responsibilities:


* The contractor shall serve as the clinical representative on project teams and support risk  planning efforts. 


* The contractor shall collaborate with project team members, leading the writing of clinical  development plans.   


* The contractor shall develop drafts and assist the project team to coordinate responsibilities,  oversee quality management, and encourage timeliness of completion of clinical study reports,  IND applications, investigator brochures, CTAs, ISEs, ISSs, and other regulatory submissions and  clinical expert reports.  


* The contractor shall collaborate with both internal and external partners, contributing to data  analyses in order to create and submit clinical study results to publications or the FDA and  participating in the evaluation of safety results in clinical studies in order to assist in formulating  the emerging safety and risk/benefit profile of products in development for clinical trials and  regulatory documents (e.g., IND, investigator brochure, informed consent, etc.).   


* The contractor shall assist the regulatory team in developing a robust product development plan  to support FDA approval under the Animal Rule and establishing a link between clinical and nonclinical efficacy. 


* The contractor shall review draft clinical protocols and provide feedback.   


* The contractor shall review and search medical literature and databases in order to identify  clinical and technical information and to provide references to support clinical plans.  


* The contractor shall author and edit technical reports (e.g., overall project concepts and  descriptions, test plans and technical reports, etc.).   


* The contractor shall work closely with the non‐clinical team to bridge non‐clinical outcomes t...




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