CliniRx is known for its dedication to conducting Phase I-IV clinical trials, ensuring compliance with Good Clinical Practices (GCPs) and enhancing clinical research standards. The Clinical Research Associate (CRA) role is pivotal for monitoring trial sites and ensuring studies are executed in line with protocols and regulatory standards.
Reporting Structure:
- Reports to: Manager/Designee – Clinical Operations
- Interacts with: Internal clinical monitoring team, QA, DM, and external sites and sponsors
- Role Type: Individual Contributor
Educational Requirements:
- Graduate Degree in Life Sciences or an equivalent qualification.
Experience Required:
- 1-5 years of on-site clinical monitoring experience.
Key Responsibilities:
- Participate in investigator identification and initial qualification visits.
- Assess site capabilities for clinical and technical study management.
- Review and assist in the development of protocols, eCRFs, study manuals, etc.
- Coordinate with the Study Start-up Group for site preparation and regulatory documentation.
- Train site staff on protocols, regulatory issues, eCRF completion, and EDC systems.
- Conduct monitoring visits (pre-study, initiation, interim, and close-out).
- Ensure adherence to GCPs and CliniRx procedures through on-site checks and documentation.
- Handle investigational product accountability and inventory.
- Review clinical data for quality and integrity; resolve data queries.
- Act as a primary contact between CliniRx and the investigator.
- Attend and present at Investigator Meetings; mentor junior CRAs.
- Request site audits when necessary and perform study close-out activities.
Skills and Abilities:
- Deep understanding of the clinical research process and medical terminology.
- Strong organizational, interpersonal, and communication skills.
- Ability to manage multiple priorities and work independently within a team.
- Proficiency in electronic data capture and basic data processing.
- Up-to-date knowledge of GCP/ICH guidelines.
Personal Attributes:
- Excellent communication and organizational skills.
- Ability to work in a matrix team and independently.
- Computer literacy is essential.
- Willingness to travel up to 50-75% domestically and internationally.
