Clinical Research Associate
hace 23 horas
Job Summary
As a Clinical Research Associate at Premier Research, you will play a crucial role in transforming life-changing ideas into reality. You will be working in a friendly environment with colleagues who are genuinely supportive.
Responsibilities:
- Deliver high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Schedule site visits for monitoring as required by protocol monitoring visit windows.
- Ensure the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 14155, and customer requirements.
- Monitor data – remotely, on site, and via other approved modes – with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Prepare for and conduct qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Manage query resolution with study sites and Premier Research data management operations.
- Participate in Investigators' Meetings as assigned by Project Managers.
- Ensure adherence to study timelines and budgets.
- Identify and escalate potential risks and identifying retraining opportunities for site study teams.
- Mentor junior-level staff and share knowledge and best practices.
- Participate in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
- Assume additional duties on certain projects, such as clinical management for smaller or less complex studies.
Requirements:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
- Prior experience in monitoring of pharma trials.
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication skills.
- Fluency in written and verbal English is mandatory; any other language is a bonus.
- Excellent organizational and time-management skills, able to meet deadlines.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
- The chance to work on exciting and challenging projects.
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