CV Profile No.50006

Experience in the following industries :

not filled in

Professional experience

• Senior Clinical Research Associate
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• Since 08.2020
• • Work independently and proactively to coordinate all necessary activities required to set up and monitor a study. • Complete accurate study status reports and maintaining study documentation • Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested • Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required • Manage sponsor generated queries efficiently and responsible for study cost effectiveness. Independent field monitoring experience- all types of visits. • Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data • Excellent communication and interpersonal skills, both written and verbal enabling to deal with queries in a timely manner • Ability to produce accurate work to tight deadlines within a pressurized environment

• Clinical Research Associate II
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• 05.2018 - 08.2020
• • Organized investigator meetings, as necessary. • Participated in Project Team Meetings. • Kept informed of trends and developments in clinical research. • Assessed all data documentation, reports, records, transcripts, exam results for consistency with case report form. • Provided oversight of and insights into trial activities. • Verified trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded. • Identified and investigated discrepancies in study documentation by applying clinical protocol and GCP knowledge and developed processes to mitigate reoccurrence throughout study phases. • Conducted reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices. • Traveled to field sites to monitor studies. • Planned and prepared studies. • Reviewed study protocols, reports and manuscripts. • Collected and maintained legal and regulatory documentation, as applicable. • Ensured accurate and complete study management/data collection and transfer to data management. • Ensured site compliance with regulations and study protocol. • Monitored the sites and provided technical assistance