Clinical Research Associate (CRA) - A

Location: Santa Clara, California
Posted On: 8/7/2017
Job Code: CRA_CA_65488
Job Description
Position Details:
Job Title: Clinical Research Associate (CRA) - A
Location: Santa Clara, CA - 95054
Duration: 06+ Months Contract

Primary Job Function:
The clinical research associate (CRA) is responsible for assisting with clinical trial management, site management, and data review while ensuring the trial is conducting in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/work instructions. The CRA will perform all job responsibilities by implementing and maintaining the effectiveness of company’s quality system.

Core Job Responsibilities
Conducts standard pre-study; initiation; interim; and close-out monitoring visits and completes site visit reports
Ensures site compliance with regulations and study protocol
Identifies and qualifies clinical investigators and clinical sites
Prepares clinical study documents
Proposes and negotiates budgets for clinical studies. Initiates payment to sites
Obtains and reviews all required essential documents necessary for study initiation
Reviews and monitors clinical data generated by Clinical Affairs
Reviews data; prepares and presents clinical data reviews and data summaries
Ensures accurate and complete study management/data collection and transfer into the data management system
Maintains accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports to keep management and team informed
Ensure compliance with Good Clinical Practices, regulations, SOPs, and protocols
Acquires and maintains technical knowledge of product line(s)

Minimum Expertise:
Minimum of 1 year clinical related experience
Candidates must have exceptional documentation skills, preferable in the FDA regulated industry
Must communicate effectively both oral and written to all leadership levels and external sites/investigators
Must be accountable for own tasks and a team player willing to support others when needed
Must be familiar and have experience with clinical regulations and standards affecting IVDs
Clinical Laboratory certification (MT; ASCP or equivalent) or IVD experience preferred
Minimum Bachelor’s degree
B.S. in biological sciences or medical specialty preferred
Up to 50% travel may be needed
Category:Non-IT  code:new
Job Requirements

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Contact Details
Naman Pandya