Senior Clinical Research Associate, Santa Monica

Integrated Resources, Inc ( IRI ) provided pay range
This range is provided by Integrated Resources, Inc ( IRI ).
Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$*****/hr - $*****/hr
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Lead Recruiter at Integrated Resources Inc.
Job Title:
Clinical Trials Management Associate - III
Location:
Considering local candidates to any of the west coast sites: Santa Monica, El
Job Duration:
12+ Months (Possibility of Extension)
NOTE:
Working mostly remote but subject to change to comply with policy.
Job Description
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 supervisors, coordinate 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.
Participate or effectively run 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, participate in two or more departmental or interdepartmental strategic initiatives.
Travel is 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 the measured efficiency 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.
Specific Education & Experience Requirements
4+ years of experience and a BS or BA in a relevant scientific discipline.
4+ years of experience and an RN (2- or 3-year certificate).
CCRA or other certifications desired.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Science, Research, and Other
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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