We're accelerating life-changing therapies by combining cutting-edge technologies, expertise, and operational scale.
Role Overview
The Clinical Research Associate II/Senior CRA supports study sites and clinical project teams. They adhere to protocols, SOPs, and regulatory requirements like ICH-GCP and local guidelines. This role requires a strong team player with independent judgment and critical thinking.
Key Responsibilities:
* Oversee site management to ensure patient safety and quality data.
* Provide guidance on audit readiness and support preparation for audits.
* Update and maintain trial management tools and status reports.
* Manage site startup procedures, including feasibility and recruitment of investigators.
* Verify informed consent processes and assess factors affecting subject/patient safety and data integrity.
* Conduct site visits, prepare monitoring reports, and document activities.
* Routinely review the Investigator Site File (ISF) and Trial Master File (TMF).
* Communicate effectively with site personnel and clinical stakeholders.
* Develop good working relationships with investigators and study staff.
* Perform investigational product inventory, reconciliation, and reviews.
* Data review, query resolution, and identifying Serious Adverse Events.
Requirements
To succeed in this role, you'll need:
* A strong understanding of clinical research and regulatory guidelines.
* Excellent communication and interpersonal skills.
* Ability to work independently and as part of a team.
* Strong problem-solving and analytical skills.
* Proficiency in trial management tools and technology.
What We Offer
We offer a competitive compensation package, opportunities for career growth and development, and a dynamic work environment that values teamwork and collaboration.