Assists in the development and monitoring of clinical trial budgets, including but not limited to, site selection, protocol, informed consent, source documentation, regulatory document review, case report form (CRF), study
Conducted site training for new CRAs in ICH/GCP guidelines and clinical trial management. Ensured compliance with protocol, SOPs, and ICH guidelines.
Perform site recruitment, screening, and enrollment; prepare and conduct research study visits. Conduct periodic monitoring of all trials.
Cardiovascular monitoring Phase III-IV research studies in accordance with ICH/GCP guidelines. Developed and implemented study plans.
Worked closely with the clinical research associates and other CRAs to ensure that the monitoring plan was completed and in accordance with ICH/GCP guidelines.
Conducts site visits for the development of the study protocol, including but not limited to, the following: recruitment, enrollment, assessment, and integration.
Palm Beach Tan
Assist in the development of study specific documents for IRB submissions and renewals. Participate in writing and review of regulatory documents.
Conduct site visits, including but not limited to, protocol, CRF completion, and writing of study visit reports.
Assist in the development of protocols, amendments, and other documents as required by the study protocol, the IRB, and the regulatory agency.
Performed source document verification, CRF design, and query resolution for study sites. Developed and implemented site specific training plans.
Assist in the development of regulatory documents for submission to the IRB. Maintain regulatory documents for the study. Prepare and submit regulatory documents to the IRB.
Prepared and submitted regulatory documents for submission to IRB. Participated in writing and submitting study protocols. Maintained and updated regulatory files.