Ref #: 25552

Employment type: Permanent - Full-Time

Location: U.S. - CA - Valencia

Description

DOCS in looking for an In-House Clinical Research Associate to work on Medical Device Studies.

Acts as an In-House Clinical Research Associate, works with clinical project teams and Clinical Research Associates to support the completion of clinical trial documentation processes, budgets, contracts and device management. Provides support to clinical functions and site customers through study and site start up, enrollment, follow up and closure phases of clinical trial activities.


Key Responsibilities:

• Manage Study Master File(s).
Documentation:
Collect study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database.
• Manage study and site document archives (paper and/or electronic) as required.
• Direct communication with site personnel to collect core trial documents, including training documents, and file in accordance to the Study Master File.
• Assembly & distribution of study documents & mass communications (e.g. Manual of Operations, Study Tools, Newsletters, Annual Reports).
• Monitor and report project-specific training compliance, for site and internal team.
• Manage site/contact/study information using appropriate tool(s).
• Review Informed Consent Form and assist with IRB submission(s) and review of IRB documentation.
• Site Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. Partner with other team members to support patient enrollment.
• Collaboration: participate in study-specific meetings, teleconferences and trainings. Collaborate with cross-functional team members and study sites throughout all study phases.
• Solid understanding and working knowledge of Clinical Study Regulatory requirements.

Requirements:

• Bachelor’s degree and 4+ years of related experience
• Experience working with CTMS and eTMF systems
• Experience with ICF (Informed Consent Form) review

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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