Aravindh Kumar Ankati

Central Monitor Ii @Syneos Health

Telangana, IN

Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution. Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data. Assesses factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete. Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan. Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

JNTUH College of Engineering Hyderabad

Bachelor's degree

State Board of Technical Education and Training

Diploma

JNTUH College of Engineering Hyderabad

Master's degree