Clinical Research Associate, FSP
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Job Description
Clinical Research Associate monitoring sites, data, safety, and compliance for Parexel’s clinical development services. Supporting trial timelines, audits, issue resolution, and junior CRA mentoring.
Responsibilities:
- Implement and monitor clinical trials to ensure sponsor and investigator obligations are met
- Assess qualification of potential investigative sites
- Initiate clinical trials at investigative sites and instruct site personnel on proper trial conduct
- Close clinical trials at investigative sites
- Review and verify accuracy of clinical trial data on site or remotely
- Provide regular site status information to team members and trial management
- Update trial management tools and applicable tracking systems
- Complete monitoring activity documents required by SOPs or contractual obligations
- Collaborate with clinical team members to resolve trial and clinical issues
- Escalate site and trial-related issues until resolved or closed
- Perform essential document site file reconciliation
- Perform source document verification and query resolution
- Assess investigational product accountability, dispensation, and compliance
- Verify SAE reporting according to trial specifications and ICH GCP guidelines
- Communicate with investigative sites
- Ensure required training is completed and documented
- Serve as the main observer/assessor of site activities
- Facilitate audits and audit resolution
- Undertake related duties such as protocol amendment submissions and Investigator site budget negotiation
- Mentor junior-level CRAs and serve as a resource for new employees
- Perform additional clinical operations tasks and advanced-negotiation clinical tasks as assigned
- Interact with other functional areas to resolve site issues and facilitate trial timelines
Requirements:
- Compliance with applicable local regulatory requirements and ICH GCP guidelines
- Experience appropriate for mentoring junior-level CRAs and serving as a resource for new employees
- Ability to perform clinical trial monitoring, site qualification, initiation, instruction, close-out, and remote/on-site data review
- Ability to perform source document verification, query resolution, essential document reconciliation, and investigational product accountability
- Ability to verify SAE reporting according to trial specifications and ICH GCP guidelines
- Ability to facilitate audits and audit resolution
- Ability to negotiate Investigator site budgets when assigned
- Ability to complete required training and documentation
- Ability to communicate with investigative sites and collaborate with clinical team members
- Ability to use applicable clinical trial tracking and management systems
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