Clinical Trials Specialist
hace 1 día
As a key member of our team, you will be responsible for ensuring the smooth start-up and maintenance of clinical trials in assigned countries. This includes coordinating with investigative sites, collecting and organizing required documents, and interacting with regulatory authorities to ensure compliance with applicable regulations and guidelines.
Key Responsibilities- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
- Coordinate, collect, and organize data and information required by regulatory authorities, including preparation of study documentation and submission to IRB/IEC/Third body/Regulatory Authorities.
- Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities and liaise with them as applicable regarding submission/approval.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
- Perform a review of final submission documents as applicable.
- Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
- Prevent and escalate study issues appropriately and in a timely fashion.
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision.
- Strong knowledge of regulatory legislation, guidance, and practice in assigned countries.
- Excellent communication and organizational skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office and clinical trials software.
- Ability to adapt to changing priorities and deadlines.
At MEX Labcorp Clinical Development, S. de R.L. de C.V., we offer a dynamic and collaborative work environment, competitive compensation and benefits, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical trials, we encourage you to apply for this exciting opportunity.
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