HARITHA K

Dedicated clinical research professional with 2+ years of experience as Clinical Research Coordinator and TMF Specialist I. Currently working as Data Entry Operator in a reputed CRO "Phoenix Clinical Research" Dubai, UAE. Seeking a position to bring my knowledge, skills and abilities which I learned through experience to a forward-thinking company where I can contribute to long term growth while continuing to evolve professionally.

• Secured University First rank in MSc. Biotechnology
• Attended molecular biology workshop (Hands on training)
• Attended science workshop organized by IISER, Thiruvananthapuram on 2016
• Have MEDIDATA and RDC training certificate

• Handling and coordinating with Multiple Sites with Multiple Clinical Trials
• Dealt with Site Identification, Initiation and Site Selection Visits (onsite) and also
• Dealt with Patient Recruitment and scheduled Patient visits according to protocol
• Coordinate with Principal Investigator and Sub I for Trial related activities of Specific Study including Internal and Investigator meeting.
• Completes Feasibility Questionnaire within timeline in order to initiate site for studies
• Coordinates and keeps track on Documentation- handling/maintenance of site manuals, patient files and reports, Monitoring and QA audits findings, TMF/ISF, Accountability/ordering, packaging, shipping and tracking of site supplies and materials of specific studies
• Ensure all documentation aligns with ICH-GCP, SOPs and regulatory requirements
• Coordinates Initiation, site monitoring and close out monitoring
• Takes initiative in problem solving and ensure timely and accurate reporting of Adverse Events and other safety related data as per regulatory requirements.
• Proficient in data entry/management on EDC/eCRF(MEDIDATA, BIZNET and RDC) of different studies
• Handling and coordinating the responsibilities of Study Team &Providing Training to the new Trainee Coordinators.
• Handling with Clinical Trial Agreements of Specific study
• Coordinating with Ethics Committee/Institutional Review Board related activities.
• Storing of all the essential clinical trial documents right from study start up to study close out in electronic TMF after indexing and reviewing (QC) the document as per Masterlist.
• Responsible for filing Study/ Country / Site level documents within the timeline in eTMF
• Participate in and contribute to the TMF compliance meeting

• Oncology (Breast cancer)
• Ophthalmology
• Nephrology
• General Medicine and General Surgery
• Observational, Phase 3, Phase 4

• Confident
• Goal-oriented
• Adaptability and flexibility
• Communication skills
• Self-motivating and hard working
• Learning ability