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Senior Clinical Research Monitor
2 months ago
This position offers the flexibility of remote work.
Position: Senior Clinical Research Associate - Direct Hire Opportunity
Location: Remote with potential travel requirements
Qualifications: A Bachelor's degree in a relevant scientific field along with a minimum of 1.5 years of experience in site monitoring within clinical research as a Clinical Research Associate (CRA). Candidates must be willing to travel to designated sites in various regions.
Compensation: Salary is negotiable based on experience.
Note: Sponsorship is not available for this position.
Key Responsibilities:
- Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, ensuring comprehensive visit reports are generated.
- Maintain the integrity of the study while fostering positive relationships with site personnel.
- Assess trial performance at various sites, ensuring compliance with protocols and safeguarding the rights and welfare of human subjects.
- Collaborate with clinical sites to devise patient recruitment strategies that align with enrollment timelines while adhering to approved standard operating procedures (SOPs), protocols, Good Clinical Practice (GCP), and applicable regulatory standards.
- Evaluate the quality and accuracy of reported data, site efficacy, and drug accountability.
- Ensure completeness and quality of regulatory documentation, performing thorough site document verification.
Required Qualifications:
- Bachelor's degree in a scientific discipline.
- A minimum of 1.5 years of experience in clinical research monitoring as a Clinical Research Associate (CRA).
- Ability to work independently with a proactive approach and minimal supervision.
- Capability to manage multiple tasks and navigate various unpredictable scenarios while adhering to project timelines and understanding study protocols.
- Proficient computer skills, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and Microsoft Excel and Word.
- A client-focused mindset with a flexible attitude towards assignments and a willingness to learn.
