Assist in the development and implementation of the clinical research Associate, including the preparation of monitoring reports, ensuring that all study protocols are met, and reporting to the sponsor and the IRB.
Lead and participate in the development of study plans, including but not limited to, protocol, CRF design, monitoring Plan, trial Master file, and quality assurance.
Participates in the development and implementation of clinical trial management systems, including the audit of the trial Master file, ensuring that all protocols are followed and compliance with the protocol.
Manage the development of study protocols, informed consent forms, case report forms, monitoring Plan, and study manuals, and ensure that all testing are conducted in compliance with SOPs and guidelines.
Coordinate and participate in the development of study-specific protocols, including but not limited to, protocol, informed consent, source document preparation, budget, trial design, and study start up.
Monitor and ensure that all clinical trials are carried out according to the study protocol, SOPs, and applicable regulations and guidelines, including the monitoring of the trial.
Responsible for the screening, consenting, and enrollment of patient population to ensure compliance with protocol, GCPs, and FDA regulations; and to ensure that all clinical data is collected and entered into the electronic medical record
Review and approve all study related documents including: CTMS, site management, and investigational product inventory. Maintain and update trial Master files.
Collaborates with the Principal investigator and sub-investigators to ensure that study objectives are met. Identifies and develops solutions to problems.
Review of study files, case report forms, and clinical data in compliance with good clinical practice guidelines. Participate in the development and revision of study protocols.
Ensured that all study related activities are conducted in compliance with the protocol, good clinical practice (GCP), and the FDA.
Working closely with the CRA to ensure that study milestones are met. (e.g. CRFs, source documents, CRF).