What are the responsibilities and job description for the Clinical Research Associate (CRA) position at Intellectt Inc?
Job Title: Clinical Research Associate (CRA)
Location: Remote (MD, DC, VA)
Onsite/Remote: Remote with few site visits in Bethesda, MD
Summary: Manage clinical monitoring processes to ensure site compliance with regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Coordinate interim and closeout activities to meet study timelines and metrics. This is a contract traveling CRA position if necessary.
Primary Responsibilities
Location: Remote (MD, DC, VA)
Onsite/Remote: Remote with few site visits in Bethesda, MD
Summary: Manage clinical monitoring processes to ensure site compliance with regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Coordinate interim and closeout activities to meet study timelines and metrics. This is a contract traveling CRA position if necessary.
Primary Responsibilities
- Strong knowledge of oncology and phase 1 studies
- Review regulatory documents and monitor adherence to collection processes
- Write clinical monitoring plans, source documents, and study tools as needed
- Conduct interim and closeout site visits, document findings, re-train site staff, and implement corrective actions
- Ensure study documents (e.g., case report forms, source documents, adverse events) are complete and accurate
- Reconcile clinical supplies and drug accountability records
- Collaborate with data management to resolve data queries
- Prepare reports, letters, and other trial-related documents
- Implement and monitor processes for SAEs, safety documentation, and pregnancies
- Facilitate investigator site payments
- Maintain clinical trial tracking information and assist with audit/inspection responses
- Develop relationships with study personnel, manage study issues, and support milestone achievement
- Assist with auditing study files and document reconciliation
- Familiarity with medical terminology, protocol, clinical trial processes, regulatory requirements, and company SOPs
- Strong knowledge of oncology, preferred experience with NCI
- Understanding of ICH/GCP Guidelines and EDC processes
- Ability to establish rapport with site personnel and colleagues.
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