About the Role
We are seeking a highly skilled and experienced individual to join our team as a Clinical Trial Associate. In this role, you will be responsible for providing clinical trial capabilities in support of clinical development.
The successful candidate will ensure that investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out.
Key Responsibilities:
* Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA)(where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
* Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
* Identify, communicate, and resolve issues.
* Evaluate and incorporate country-specific regulatory and data privacy requirements into submission documents and other relevant systems.
* Utilize previous site / review board engagements to efficiently drive new work.
* Populate internal systems to ensure accuracy of trial / site performance.
* Ensure accurate documentation and storage of Trial Master Files and libraries for future reference.
* Provide feedback and shared learning for continuous improvement.
Requirements:
* Bachelor's degree preferably in a scientific or health-related field, two years' clinical research experience or relevant experience preferred.
* Understanding of the overall clinical development paradigm and the importance of efficient site activation.
* Awareness of project management processes and skills.
* Appreciation of compliance-driven environments.
* Effective communication, negotiation, and problem-solving skills.
* Self-management and organizational skills.
We offer a range of benefits to support your career growth and well-being, including flexible working options, comprehensive training programs, and competitive compensation packages.
If you are a motivated and detail-oriented individual who is passionate about delivering high-quality results, we encourage you to apply for this exciting opportunity.