Clinical Research Associate

Description:

1. Performs site qualification, initiation, interim and close-out monitoring visits.
2. This role ensures compliance with clinical trial protocols and regulations.
3. Conducts monitoring visits at sites to perform source data verification and study file (regulatory) review and addresses identified issues directly with site staff.
4. Manages complex issues with minimal support.
5. Analyzes trends in identified issues and writes visit follow-up reports with minimal oversight and guidance. For sites with systemic issues identified, performs root cause analysis, and implements corrective and preventative actions.
6. Communicates with sites to effectively resolve issues. Provides clear and technically accurate information, both orally and in writing.
7. Participates in training junior CRAs on moderately complex concepts, processes, and tasks.
8. Manages moderately complex projects as assigned under the direction of the Clinical Project Manager.
9. Creates and/or contributes to the development of monitoring/audit tools and materials (e.g., project-specific work instructions, training materials, newsletters).
10. May participate in the development of study protocols, case report forms, and clinical monitoring plan and provides expert input.
11. Authors and reviews drafts of project-specific forms instruction manuals/CRF completion guidelines.
12. Other duties as assigned.
    

Additional Skills & Qualifications:

1. Clinical research study processes, study design and/or protocol management.
2. Clinical trial monitoring procedures and clinical data reporting processes.
3. ICH GCP guidance and FDA regulations.
4. Medical terminology and anatomy/physiology.
5. Microsoft Suite of software products.
6. Intermediate project management, training, and conflict resolution skills.
7. Perform tasks requiring excellent attention to detail.
8. Manage multiple deadlines and priorities while ensuring quality and timeliness.
9. Work effectively and efficiently in a remote environment.
10. Travel up to 70% of time (domestic and international).