Responsibilities
- Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.
- Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.
- Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Team
Reports to: Director of Clinical Operations, Dennis McHugh
Additional Information
- Contractor role may be hired through a third-party provider.
- Contingent worker status.
- Occasional travel to Brisbane, California headquarters as required.
- Equal opportunity employer.
- Non-discrimination policy covering federal, state, and local protected classes.
- Applicants have rights under FMLA, EEO, and EPPA.
