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Clinical Research Specialist
3 semanas atrás
As a clinical research specialist, you will play a vital role in advancing global healthcare through innovative research and development. Your expertise will be instrumental in ensuring the safety and efficacy of our products through rigorous clinical trials and surveillance.
Key Responsibilities:- Develops and maintains strong relationships with study sites to ensure seamless collaboration throughout all phases of the trial.
- Conducts site management/monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, and site monitoring plan.
- Gains in-depth knowledge of the study protocol and related procedures to drive informed decision-making.
- Coordinates and manages various tasks in collaboration with other stakeholders to achieve site readiness.
- Participates in site selection and validation activities to identify suitable locations for clinical trials.
- Performs remote and on-site monitoring and oversight activities to ensure data accuracy, subject well-being, and regulatory compliance.
- Conducts site visits, including initiation visits, monitoring visits, close-out visits, and records clear and comprehensive visit reports in a timely manner.
- Communicates effectively with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, and overall site performance.
- Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates concerns as needed.
Requirements:
- Strong understanding of clinical research principles and practices.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office and clinical trial management software.
- Experience with ICH-GCP, sponsor SOPs, and regulatory requirements.
Benefits:
- Competitive salary and benefits package.
- Ongoing training and professional development opportunities.
- Collaborative and dynamic work environment.
- Opportunities for career growth and advancement.
What We Offer:
We are committed to fostering a culture of innovation, teamwork, and excellence. If you are a motivated and detail-oriented individual who is passionate about advancing global healthcare, we encourage you to apply for this exciting opportunity.
