Clinical Research Observer

Job Description

Job Description

Summary : The Clinical Research Observer provides expert, objective observational assessments during clinical trial visits, ensuring protocol adherence, high‑quality source documentation, and maintenance of blinding where applicable. This role leads rater calibration and supports data integrity in line with ICH GCP, ALCOA‑C+, HIPAA, and site SOPs.

Duties and Responsibilities : The Clinical Research Observer :

• Continuously monitors and objectively documents participant behavior using designated study forms / eSource in accordance with ALCOA‑C+, protocol requirements, and site SOPs.
• Observes and records participant responses during scheduled assessments (e.g., adhesion scoring, sedation, irritation, and other protocol‑specified clinical evaluations) per the protocol, lab manual, and blinding requirements.
• Completes and maintains all required trainings and certifications prior to participating in the study, including ICH GCP, IATA / Dangerous Goods, protocol and lab manual trainings, and any observer‑specific certifications; (Senior level) maintain calibration / inter‑rater reliability as required by sponsor / CRO.
• Collaborates professionally with Elixia site staff, facility staff, patients, and caregivers to support compliant visit execution; promptly communicate issues, required corrections, or potential deviations to the study team and follow HIPAA, ICH GCP, and site SOPs.
• Occasional travel to Company sites, Investigator meetings, and / or Company meetings.
• Performs other miscellaneous job-related duties as assigned by your manager.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Qualifications :

Continuing Education :

Competency Requirements :

Physical Requirements and Environmental Factors :