Senior Clinical Research Associate (Cell & Gene Therapy)
New
Remote, USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5–7+ years
- Required Skills
- MS Office
Requirements
- Bachelor’s degree (life sciences, nursing, or related field preferred)
- 5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience)
- Cell and Gene Therapy experience required
- Broad therapeutic exposure across multiple study types and indications
- Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols
- Advanced organizational and logistical skills
- Excellent written and verbal communication
- Solid understanding of medical/therapeutic areas and medical terminology
- Proven ability to train, coach, and mentor clinical research staff
- Proficient with MS Office and EDC systems
- Willing to travel up to 80%
Responsibilities
- Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans).
- Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection.
- Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements.
- Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations.
- Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready.
- Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions.
- Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence.
- Track and close action items within study or company timelines; maintain clear oversight of monitoring deliverables.
- Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates.
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