Clinical Research Associate III
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POST DATE 8/18/2016
END DATE 12/1/2016
JOB DESCRIPTIONJob Description
This position is responsible for providing a senior or lead CRA role and oversight assistance in the planning, coordination, execution, monitoring and reporting of clinical trial
Oversees assigned protocol(s) with multiple sites to ensure compliance with GCP, ICH/FDA regulations and guidances , and department SOPs.
Provides leadership and guidance to the assigned CRAs to ensure planning, coordination and execution of all assigned tasks. Oversees deliverable of resources through timeline management. Assists in the training of other CRAs.
Reviews protocols, IRB submissions, informed consents, case report forms and other regulatory documents to assure compliance with FDA /GCP/ICH regulations and guidances and company policies.
Develops clinical trial monitoring plans and departmental training procedures and guidelines.
Assists in the authorship of regulatory submittals such as site/summary reports and product performance characteristics
Conducts pre-investigational , site initiation monitoring and close-out visits as needed.
EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer
To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Interfaces with project teams and will function as lead (or senior) CRA
Creates departmental Training Instructions (TI) / procedures on statistical methods as needed.
Ability to independently organize and manage multiple assignments.
Strong critical/analytical thinking and problem solving skills.
Working knowledge of MS Word, Excel and Access
Excellent interpersonal, communication, organizational and computer skills.
Ability to lead a team.
Proficient in relevant computer software.
B.A. / B.S. degree in biological sciences.
Medical Technology certification or laboratory experience desirable. CCRP certification desirable.
Five (5) years experience in clinical research / monitoring.
Full knowledge of ICH/GCP guidelines and FDA regulations and guidelines.
Previous experience with in vitro diagnostic or medical device industry and / or experience in a clinical laboratory is preferred.