[Remote] Senior Clinical Research Associate
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. The Senior Clinical Research Associate will reputed company clinical monitoring and site management, ensuring compliance with regulatory requirements and building relationships with sponsors and sites. This role involves conducting monitoring reputed company, training site staff, and managing study documentation to ensure protocol adherence.
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 reputed company 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
- reputed company and reputed company reputed company items reputed company study or company timelines; maintain reputed company 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; reputed company as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations
Skills
- 5-7+ years' experience conducting on-site and remote monitoring reputed company (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, reputed company, 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
- Bachelor's degree (life sciences, nursing, or reputed company field preferred)
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 reputed company reputed company plan and company match
- reputed company vacation, holiday, reputed company and volunteer time
- reputed company maternity & paternity leave
reputed company