Job Summary
The Clinical Research Associate, Sponsor Dedicated is responsible for conducting monitoring and oversight activities in site management. This role ensures that all processes adhere to regulatory standards and that the Investigator’s Site File (ISF) aligns with the essential documentation and guidelines.
Responsibilities
- Conduct monitoring visits to assess compliance with study protocols and regulations.
- Manage site activities to ensure the integrity of data and compliance with Good Clinical Practice (GCP).
- Verify the completeness and accuracy of the Trial Master File (TMF) and other essential study documentation.
- Provide ongoing support and guidance to site personnel regarding study-related issues.
- Collaborate closely with team members and stakeholders to facilitate successful trial execution.
Qualifications
- A background in nursing or a university degree equivalent to a US Bachelor’s degree.
- Previous experience at the site level in clinical research or a related field is desirable.
- Strong understanding of clinical trial regulations and GCP guidelines.
- Excellent communication and interpersonal skills for effective collaboration.
- Detail-oriented with robust organizational skills for managing multiple responsibilities.
IQVIA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
