Clinical Research Project Manager

ResponsibilitiesThe Clinical Research Project Manager (PM) functions as a collaborator within a Clinical Trials Laboratory Center which is sponsored by the Division of AIDS (DAIDS) / National Institute of Allergy and Infectious Disease (NIAID) / National Institutes of Health (NIH).
The employee will play an integral role in the implementation of clinical trials protocols, information management and Network organization and structure. The PM is responsible for reviewing and implementing protocol testing, reviewing laboratory quality assurance information, working with laboratories to resolve audit/monitoring visit findings and supporting capabilities required to conduct clinical trials as required by the protocol Sponsor. The PM contributes to scientific technical aspects of clinical research laboratory capacity building. The PM also provides committee coordination and administrative support to laboratory-related committees and working groups

QualificationsBachelor??s degree in science or health related field strongly preferred.
5 or more years in laboratory/project management setting.
Excellent verbal and written communication skills, which may include business and technical writing, editing and proofreading.
Excellent interpersonal and client management skills with a professional and customer service oriented demeanor.
Working knowledge of assay validation, quality assurance and quality control procedures and properly documenting laboratory processes and procedures as well as corrective actions and preventative actions (CAPA).
Knowledge in the following laboratory procedures and instruments: clinical chemistry, hematology, microbiology, virology, and immunology.
The PM must have a thorough understanding of Good Laboratory Practices (GLP)/ Good Clinical Laboratory Practices (GCLP) and CLIA regulations.
Laboratory Testing and Analysis: The PM is responsible for knowledge related to the performance of complex laboratory procedures. In addition the PM should be able to: recognize deviations from expected and/or normal results; analyze results for possible solutions; recommend new test methodologies and/or modify existing ones to achieve desired results; evaluate new laboratory techniques; prepare and analyze a variety of data; provide detailed documentation and analysis of clinical research data. Laboratory Operations:
The PM should be able to: organize and direct the daily activities of participating laboratories; participate with supervisor in work planning, staff training, evaluating work, and counseling; evaluate quality control procedures; review work of others for conformance with quality control procedures; maintain quality control records; perform safety checks; ensure compliance with health and safety guidelines.
Instruction: Ability to develop and provide instruction and training for staff at international laboratories in performance of laboratory procedures including total quality management. Ability to develop necessary training tools to assist laboratories (i.e., checklists, training materials, etc.). Experience working with laboratory data/information management systems or laboratory database.
Preferred: Medical technologist degree or prior experience implementing clinical research testing is a plus.

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