Dedicated Clinical Research professional with 4 years of experience in managing, coordinating and monitoring the Clinical Trials. Seeking to leverage expertise in advancing clinical research initiatives within a dynamic health care organization.
>Conduct site selection,initiation, monitoring and close-out visits in accordance with protocol,regulatory requirements, SOPs, and Monitoring plans
>Perform source data verification, ensuring accuracy, completeness and consistency of clinical data recorded in CRFs and EDC
>Prepare and maintain study documentation, including monitoring reports.
>Assist and train the trial staff for better outcome.
>Monitor study progress,identify and resolve issues or deviations from protocol, and provide solutions to ensure study quality.
>Participate in the study meetings, Investigator meetings and training sessions as required
>Coordinate all aspects of Clinical Trial, including participant recruitment, Screening and Enrolment.
>Schedule participant visits, Procedures and assessments according to protocol requirements.
>Maintain accurate and up-to-date study documentation, including regulatory documents,ICF,Study logs and ISF.
>Ensure compliance with Study protocol, Institutional policies and regulatory requirements.
>Communicate effectively with study participants, Investigator, Sponsor and regulatory Authorities.
>Assist with data collection, entry and quality assurance procedures
>Coordinate all aspects of Clinical Trial, including participant recruitment, Screening and Enrolment.
>Schedule participant visits, Procedures and assessments according to protocol requirements.
>Maintain accurate and up-to-date study documentation, including regulatory documents,ICF,Study logs and ISF.
>Ensure compliance with Study protocol, Institutional policies and regulatory requirements.
>Communicate effectively with study participants, Investigator, Sponsor and regulatory Authorities.
>Assist with data collection, entry and quality assurance procedures
Patient recruitment and informed consent processes
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