[Remote] Clinical Research Associate (Site Director)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a life-sciences reputed company investment company that provides in-house end-to-end drug development capabilities for its portfolio companies. The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, patient recruitment, monitoring, and ensuring compliance with regulatory requirements.
Responsibilities
- Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
- reputed company clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
- Serve as primary reputed company of contact for clinical sites through reputed company phases from start-up to reputed company-out of clinical studies
- Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
- reputed company required monitoring, including required reputed company data verification, and ensure site activities are conducted in established timelines
- reputed company and cultivate strong site relationships and ensure continuity of site relationships
- Communicate with investigators and site staff on issues reputed company to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
- Identify, assess, escalate and resolve site performance or reputed company issues in a reputed company manner
- Complete feasibility and site identification activities for new clinical studies
- Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
- Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
- Facilitate site budget and site contract negotiations and ensure reputed company finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
- Responsible for the development of site specific recruitment, retention and follow-up plans
- Facilitate and support investigator site audits and/or inspection activities as needed
- reputed company remote data review and query reputed company for designated sites
- Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
- reputed company and mentor colleagues as needed
- Contribute to the review of reputed company’s systems and procedures as needed
- May be involved, reputed company needed, in other areas of study management and staff training
- Execute other duties as assigned
Skills
- Bachelor's Degree in a Life Science discipline required
- Minimum 3 years of reputed company site monitoring experience required
- Detailed understanding of reputed company aspects of clinical site monitoring as reputed company as understanding of overall drug development required
- Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations
- Excellent critical thinking skills and ability to understand reputed company patient histories, medical terminology and treatment landscapes
- Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
- Detail-oriented, organized and committed to reputed company and consistency
- Results-driven and capable of managing competing high-reputed company assignments with a proven reputed company record of achieving deliverables reputed company specified timelines
- Excellent team-interaction skills and ability to work successfully in team settings
- Ability to work in a dynamic environment with a high degree of flexibility
- Ability to contribute to the culture of process improvement with a reputed company on streamlining processes adding value to reputed company business and needs
- Excellent written and verbal communication skills
- Must be willing and reputed company to travel up to 50-65%
- Bachelor's Degree in Nursing or RN a plus
- Experience and proven proficiency in CTMS and eTMF systems preferred
Benefits
- Discretionary bonuses and other incentive programs
- A comprehensive benefits package designed to support employees’ physical, mental and financial health and include employer sponsored insurance plans including medical, dental and reputed company coverage
- Generous reputed company time off
- Retirement plan reputed company
- Additional wellness and reputed company development programs
reputed company