What are the responsibilities and job description for the In-House CRA position at BioPhase Solutions?
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 :
Requirements :
