Seeking a full-time Senior Clinical Research Associate position at the KONA Medical. Strongly interested in conducting research in an ethical and safe manner.
Reliable Clinical Research Associate with knowledge in all areas of research including IRB protocol submissions, on-going regulatory and IRB phases. Experience as a CRA in a medical device industry and international travel. Excellent strong ethics, strong commitment to quality patient care and a proven desire for achievement and continued professional growth.
Monitored clinical trials; conducted site evaluation, initiation, interim and close-out visits; collected and reviewed data. Assessed monitoring reports; verified action items and resolution; tracked and documented all protocol deviations. Created clinical protocol implementation according to sponsor, industry, and federal guidelines; ensured compliance with multiple protocols, FDA regulations and ICH/GCP guidelines.
Initiated internal field evaluation studies. Developed and wrote trial protocols, case report forms, patient exclusion questionnaire. Set up clinical trial sites and trained the site staff. Monitored clinical trials throughout its duration, verifying that data entered on to the CRFs is consistent with patient clinical notes (SDV). Collected completed CRFs from hospitals and general practices; wrote visit reports; filing and collating trial documentation and reports; closing down trial sites on completion of the trial;
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