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Clinical Research Associate

Hyperion Therapeutics

Location:
South San Francisco, CA
Posted Date:
7/2/2014
Position Type:
Full time
Job Code:
Clinical Research Associate
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Research, Research,

Job Description

Position Purpose
Ensure timely conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.  Position reports to Associate Director, Clinical Operations.

Responsibilities
•   In conjunction with Associate Director, coordinate activities of clinical trial sites
•   Attend Site Qualification Visits to assess investigator’s staff and facilities
•   Contribute to study design and initiate planning for global programs (Protocol Amendments and ICF template revisions; Case Report form design and review; Patient instruction cards, and other study materials)
•   Assist in the preparation and review of supportive study documents and study plans (Monitoring Plan, Lab Manuals, Project Plans, IWRS, CRF Guidelines)
•   Ensure all local regulatory approvals are in place for conduct of trial
•   Conduct study initiation visits, including training of on-site personnel in all aspects of study requirements
•   Conduct monitoring visits to the sites at intervals specified in monitoring plan
•   Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate
•   Identify, assess and implement appropriate activities to ensure trial progress
•   Coordinate supplies for specimen collection and shipment of samples for assays
•   Monitor supply of investigational and comparator drug supply throughout the trial
•   Assist with product accountability at site and take appropriate action to resolve discrepancies
•   Report adverse events per protocol and Standard Operating Procedures
•   Conduct study close-out visits
•   Document all trial information with adherence to applicable guidelines and Standard Operating Procedures
•   Remain current with study data
•   Maintain high level of familiarity with clinical literature of study area

Requirements

Position Requirements
•   BA/BS in Life Science or related discipline
•   2-5 years of experience in clinical study coordination
•   Preferred knowledge of FDA regulatory requirements and medical practice/techniques and terminology
•   Ability to work within a team
•   Excellent communication and interpersonal skills
•   Attention to detail and highly organized
•   25% travel

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