Clinical Research Associate (Cra) - B

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to [email protected] or call me at +1(732) 276-1791

Role: Clinical Research Associate (CRA) - B

Location: Alameda, CA - 94502

Duration: 12 Months on W2

Shift Timings: 8 am to 5 pm

The CRA II/Senior CRA assists in managing clinical studies, overseeing various stages from planning to reporting, ensuring timelines and quality standards are met. Located in Alameda, CA.

Responsibilities

• Collaborate in cross-functional clinical teams.
• Carry out site visits, generate monitoring reports, and track action items.
• Maintain and audit Trial Master File for inspection readiness.
• Communicate study progress to management.
• Conduct medical device clinical studies at multiple sites.
• Review clinical data listings for accuracy and completeness.
• Ensure quality delivery of study results within budget and timelines.
• Manage clinical monitoring, site compliance, and adherence to protocols.
• Experience in medical device, in-vitro diagnostics, or pharmaceutical studies.
• Assist senior staff in study planning, investigator selection, and training.
• Minimum BS degree in life sciences with 5+ years' experience, or MS degree with 3+ years' experience, or PhD with 2+ years' experience.
• Handle study device shipment and accountability.
• Assist in preparing documents for regulatory submissions.
• Education and Experience:
• 5+ years of relevant experience in site monitoring and clinical project management.
• Participate in study start-up activities.
• Respond to audits and inquiries from regulatory authorities.

Skills

• Strong teamwork, interpersonal, and communication skills.
• Problem-solving and innovative thinking.
• Proficiency in Microsoft Suite.
• Adaptability to changing priorities.
• Understanding of clinical trial process, data management, and analysis.
• Knowledge of GCP and Clinical/Regulatory Affairs.
• Project management and organizational skills.

Travel Requirements

• 30-50% travel.