This is Tanmai from Intellect Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to tanmai@intellectt.com or call me at +1(732) 696-7434
Role: Clinical Research Associate (CRA) - B
Location: Alameda, CA - 94502
Duration: 6 Months on W2
Shift Timings: 8:00am to 5:00pm
Summary
The CRAII/Sr. CRA will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
Job Description
Conduct medical device clinical studies at one or multiple centers.
Visit study sites, generate trip reports, and track action item resolutions. Participate in study start-up activities.
Manage clinical monitoring and site activities to ensure compliance with protocols, regulations, and guidelines.
Assist senior staff in study planning, investigator selection, CRO management, and submission preparation.
Review clinical data listings for accuracy and completeness, reporting issues to Clinical Operations Manager.
Ensure quality study delivery within budgets and timelines.
Prepare necessary study documents (TMF, Protocols, Reports).
Interact with RA/QA for audits and FDA inquiries.
Education And Experience
BS with 5+ years experience, MS with 3+ years, or PhD with 2+ years.
Must have 5+ years experience in site monitoring, clinical project management, and trial regulations.
Experience in medical device or in-vitro diagnostics studies; pharmaceutical background considered.
Skills
Understanding of clinical trial process, data management, analysis, and reporting.
Knowledge of GCP, Clinical and Regulatory Affairs.
Proficiency in Microsoft Suite.
Travel Requirements
Expected travel of 30-50%.
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Human Resources Services
Referrals increase your chances of interviewing at TekOne IT Services Pvt. Ltd. by 2x