Clinical Research Associate
4 weeks ago
Sention Therapeutics, LLC is seeking a highly skilled Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical sites, ensuring compliance with regulatory requirements, and delivering high-quality patient data.
Key Responsibilities- Manage clinical site start-up, monitoring, and execution of Phase I-IV studies
- Perform site management and monitoring activities in compliance with ICH-GCP guidelines, SOPs, and local regulations
- Serve as primary point of contact for clinical sites throughout the study lifecycle
- Develop and maintain strong site relationships and ensure continuity of site interactions
- Communicate with investigators and site staff on protocol conduct, recruitment, and site performance
- Identify, assess, and resolve site performance or quality issues in a timely manner
- Conduct feasibility and site identification activities for new clinical studies
- Prepare and collect essential documents for regulatory and IRB/EC submissions
- Facilitate site budget and contract negotiations and ensure timely finalization of clinical trial agreements
- Develop and implement site-specific recruitment, retention, and follow-up plans
- Support investigator site audits and inspections as needed
- Perform remote data review and query resolution
- Bachelor's Degree in a Life Science discipline required
- Bachelor's Degree in Nursing or RN a plus
- Minimum 3 years of direct site monitoring experience required
- Detailed understanding of clinical site monitoring and overall drug development
- Thorough understanding of FDA, ICH, and GCP guidelines and applicable local regulations
- Excellent critical thinking skills and ability to understand complex patient histories and medical terminology
- Ability to interpret study-level metrics data and proactively identify and mitigate risks
- Detail-oriented, organized, and committed to quality and consistency
- Results-driven and capable of managing competing high-priority assignments
- 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 and streamlining processes
- Excellent written and verbal communication skills
- Experience and proficiency in CTMS and eTMF systems preferred
- Must be willing and able to travel up to 50-65%
Sention Therapeutics, LLC is an Equal Opportunity employer and does not discriminate against applicants or employees based on race, creed, color, religion, sex, national origin, ancestry, age, sexual orientation, physical or mental disability, or veteran status.
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