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In-House CRA
BioPhase SolutionsSan Diego, CA, US
1 day 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.