Premier Life Sciences LLC Hiring for Clinical Research Associate at United States Full Time

Role: Clinical Research Associate

Location – Remote – Few Site visits will be in Bethesda, MD (If Needed)

Duration: Long Term on W2 – No C2C

Primary Responsibilities:

• Ensure site adherence to regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols.
• Coordinate interim and closeout activities for clinical trials to meet timelines and metrics.
• Perform regulatory document review and ensure adherence to the regulatory document collection process.
• Write clinical monitoring plans, source documents, and other study tools as needed.
• Conduct monitoring/co-monitoring activities for interim site monitoring and closeout visits.
• Document site findings and implement corrective actions and follow-ups.
• Verify study documents for completeness and accuracy to ensure data integrity.
• Reconcile clinical supplies and drug accountability records at study sites.
• Collaborate with data management to resolve queries.
• Prepare and document site visit reports, confirmation letters, and follow-up letters.
• Monitor compliance with SAE, safety documentation, and pregnancy processes.
• Facilitate investigator site payments, if applicable.
• Review and track trial newsletters, memos, and other trial-related documentation.
• Maintain clinical trial tracking information and assist with auditing study files.
• Communicate with study personnel to manage study issues, support milestone achievement, and answer study questions.
• Assist with effective and timely audit/inspection responses.
• Prepare reports and documents on study progress for the study manager.
• Review study-specific ICF(s) for compliance with ICH/GCP and company SOPs.

Knowledge, Skills, and Abilities:

• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Strong knowledge of the assigned therapeutic area, particularly oncology.
• Experience with NCI is preferred.
• Proficient in ICH/GCP Guidelines and the EDC process.
• Ability to establish rapport with site personnel and colleagues.