Clinical Trials Management Associate - II

 
Location: Foster City, California
Posted On: 6/14/2017
Job Code: CTM2_CA_3249
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Category:IT code:new HBR
 
Job Description
 
• Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel is required.
Category:IT  code:new
 
 
Job Requirements
 
 
• Excellent verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.

If you are interested in the role then please revert with an updated resume in word format.
 

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Contact Details
 
Recruiter
Riya Jain
 
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