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Lead Clinical Research Associate
2 months ago
When our values align, there's no limit to what we can achieve.
The Clinical Research Associate serves as the primary liaison for clinical sites, responsible for overseeing site quality and performance from the initial identification phase through to study close-out. This role focuses on fostering strong relationships with sites, ensuring accountability for site performance, and implementing effective patient recruitment strategies. Key responsibilities include:
Start-up Phase Responsibilities:
- Establishing connections with investigators and site personnel.
- Conducting feasibility assessments and site qualifications, including:
- Preparation and negotiation of Confidentiality Agreements and Clinical Site Agreements.
- Performing remote Qualification Visits.
- Generating detailed visit reports to identify and resolve site-related issues.
- Developing and managing essential regulatory documents and Informed Consent Forms tailored to specific sites.
- Submitting necessary applications to IRB/IEC and other regulatory bodies, ensuring timely follow-up until final approvals are obtained.
- Maintaining Clinical Trial Management Systems (CTMS) with up-to-date information.
Maintenance Phase Responsibilities:
- Assessing and ensuring compliance with study protocols at clinical sites.
- Supporting sites in accessing relevant study systems and ensuring adherence to training requirements.
- Addressing site issues and implementing corrective actions as needed.
- Conducting regular on-site visits to evaluate staff performance and site compliance.
- Collaborating with site staff to enhance recruitment strategies and overall study performance.
Overall Accountabilities:
- Ensuring timely completion of project objectives and maintaining accurate trial management records.
- Upholding compliance with ICH-GCP and applicable regulations.
- Fostering a collaborative and results-oriented work environment, while demonstrating commitment to high-quality work and continuous improvement.
Skills Required:
- Strong problem-solving abilities and initiative.
- Excellent communication and presentation skills.
- Proficiency in Clinical Trial Management Systems and MS Office applications.
- Ability to work independently and in a team-oriented environment.
Knowledge and Experience:
- Significant experience in site management or clinical research, with a solid understanding of clinical trial methodologies.
Education:
- A degree in biological sciences, pharmacy, or a related health discipline is preferred.
EEO Disclaimer:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.
