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Reference Number:
USA_2706
Job Description:
Manpower is looking for a Clinical Research candidate with medical review record experience for our client in the bay area. If interested, please contact Kim Nguyen at 408.557.2729.
Principal functional responsibilities:
-Participates in the ongoing science/medical review and cleaning of study data, SAE report process according to SOP's, reconciliation of clinical and safety databases
- Assists in narrative writing for SAEs for Clinical Study Reports
- Assists in establishing glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries
- Participate in the review and organization of data for final study reports
- Assist in providing response to regulatory agency questions and preparation of advisory committee meetings
- Provide input for phase IIIB or publication studies; review phase IIIB protocols
- Assists in coordinating, preparing, and reviewing study results
- Assists in quality and timely preparation and review of all relevant documents
- Participates in routine review of laboratory results and ensuring appropriate follow-up for pre-defined safety parameters
- Assists in routine writing of narratives for SAEs and other events as requested
- Participates in ongoing review of efficacy and safety outputs and query information as appropriate
- Assists in ensuring correct data interpretation including interim and Final Study Reports before they are approved
- Task priorities and schedules within a project as well as time schedule in view of the next assessment points for projects
- Assists in assuring that the SOPs for evaluation, documentation and reporting of SAEs are strictly followed within PDCV and together with PDS assesses the etiology/causality of SAEs and laboratory abnormalities
- Attends appropriate orientation and training for employees
Qualifications and experience:
- RN, MD, PharmD, or equivalent scientific/medical qualification minimal with clinical experience preferred, therapeutic area experience a plus
-Two to Five years Industry experienced, particularly in Clinical development and Drug safety
- Fluent in English
Experience Level:
3 Years
Requirements:
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