Job Description
The role of a Clinical Trial Specialist is pivotal in the setup and execution of clinical trials. The incumbent will be responsible for coordinating site selection, regulatory document preparation, and study material distribution.
Key responsibilities include collaborating with cross-functional teams to ensure alignment on study protocols, timelines, and operational requirements.
* Ensure compliance with Good Clinical Practice (GCP) and other regulatory guidelines throughout the study setup phase.
* Provide ongoing support to study teams and sites, addressing any issues that arise during the trial setup process.
* Maintain accurate records and documentation related to study setup activities.
Requirements:
* A Bachelor's degree in a relevant field such as life sciences, clinical research, or healthcare management.
* Experience in clinical trial setup, regulatory submissions, or site management, preferably within the pharmaceutical or biotechnology industry.
* Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
* Excellent organizational skills and attention to detail, with the ability to manage multiple setup tasks simultaneously.
* Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and stakeholders.