Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the oversight and management of clinical trials. The CRA ensures that studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company policies. This position is integral to the success of clinical research initiatives, contributing to the advancement of medical knowledge and therapeutic options.
Responsibilities
- Monitor the progress of clinical trials, ensuring adherence to protocols and timelines.
- Perform site visits to conduct essential monitoring activities and identify issues.
- Ensure proper documentation and reporting of trial data and compliance with regulatory standards.
- Collaborate with site personnel to facilitate training and address any trial-related concerns.
- Assist in the selection and initiation of clinical sites, as well as maintaining relationships with investigative staff.
- Evaluate and communicate findings from site visits, providing necessary feedback and guidance to the sites.
- Participate in audit preparations and inspections as required.
Qualifications
- Bachelor’s degree in a relevant scientific or healthcare field.
- Previous experience in clinical research and a solid understanding of clinical trial methodology.
- Strong analytical skills, attention to detail, and the ability to work independently.
- Effective communication and interpersonal skills, enabling productive professional relationships.
- Knowledge of regulatory requirements and GCP guidelines.
- Willingness to travel to different study sites as needed.
Ke`aki Technologies 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.
