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In-House CRA

In-House CRA

BioPhase SolutionsSan Diego, CA, US
2 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Summary

We are seeking a motivated individual to join our Clinical Department as an In-House Clinical Research Associate (CRA). Ideal candidates will be self-driven and committed to generating high-quality data within an innovative research team. The CRA will support the administration and progress of clinical trials, ensuring compliance with protocols for accurate data collection.

Location

San Diego – onsite

Responsibilities :

  • Assist in identifying and setting up trial sites with necessary materials.
  • Manage study start-up activities and track metrics (e.g., feasibility data, consent form review).
  • Ensure regulatory compliance with SOPs, FDA regulations, and ICH guidelines.
  • Review and approve monitoring visit reports.
  • Identify potential data collection issues through periodic data reviews.
  • Collect completed Case Report Forms (CRFs) and maintain the Trial Master File.
  • Support the data query process and verify internal data listings.
  • Generate reports and manage trial documentation.
  • Track patient enrollment and recommend solutions to enhance recruitment.
  • Utilize clinical trial databases (e.g., EDC, CTMS) for reporting.
  • Assist in preparing study documents and designing materials (CRFs, patient diaries).
  • Participate in protocol development and study reports.
  • Coordinate training materials for site staff.
  • Archive study documentation and correspondence.
  • Contribute to research reports and presentations.
  • Establish relationships with collaborative partners and maintain safety standards.
  • Other duties as assigned.

Qualifications :

  • BA / BS in a health-related field; clinical research or life sciences preferred.
  • Minimum 5 years of relevant clinical research experience.
  • Experience in clinical research monitoring or as a study coordinator.
  • Knowledge of GCP, ICH guidelines, and FDA regulations.
  • Proficiency in Microsoft Office Suite.

    • Requirements :

  • Ability to work independently with minimal supervision.
  • Excellent written and verbal communication skills.
  • Strong problem-solving skills and proactive approach.
  • Understanding of project timelines and coordination with stakeholders.
  • Adaptable and flexible in managing multiple demands.
  • Self-motivated with strong interpersonal and organizational skills.