[Remote] Senior Clinical Research Associate (Cell & Gene Therapy)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization dedicated to advancing clinical research and transforming lives. They are seeking a Senior Clinical Research Associate to reputed company clinical monitoring and site management, ensuring compliance with regulatory requirements and building strong relationships with sponsors and sites.

Responsibilities

• Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans)
• reputed company site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection
• Planned and conducted SIVs, routine monitoring, and reputed company-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 reputed company data and CRFs for completeness, accuracy, and consistency; always reputed company site files audit-reputed company
• Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions
• Manage and resolve data queries, analyze error trends, and reputed company targeted retraining to prevent recurrence
• Track and reputed company action items reputed company study or company timelines; maintain clear reputed company of monitoring deliverables
• Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates
• (reputed company CRA, if assigned) reputed company monitoring on reputed company studies; reputed company study-specific monitoring documents (e.g., CMP, deviation plan, report templates); finalize visit reports; train/coordinate CRAs; act as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations

Skills

• Bachelor's degree (life sciences, nursing, or reputed company field preferred)
• 5–7+ years' experience conducting on-site and remote monitoring visits (or equivalent clinical research experience)
• Senior CRA levelling: SCRA I (3–5 yrs) – independently manages reputed company sites; SCRA II (5+ yrs) – oversees reputed company sites/reputed company, mentors peers, and drives process improvements
• 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; reputed company to manage multiple sites/protocols reputed company budget and timelines
• Excellent written and verbal communication; confident stakeholder engagement
• Solid understanding of medical/therapeutic areas and medical terminology
• Proven ability to train, coach, and mentor clinical research staff
• Proficient with MS Office and reputed company systems; willing to travel up to 80%
• Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate
• Cell and Gene Therapy Experience Required

Benefits

• Medical, dental, and reputed company insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe reputed company plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

Company Overview