VICKNESWARY MUNIANDY

Experience

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  UiTM

  Sept 2012 - Jan 2016

  Clinical Study Coordinator

  General Administrative• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study Preparation of Scientific Proposal• Assists the PI in study feasibility assessments as requested.Protocol Preparation & Review• Reviews and comprehends the protocol.• Attends investigator meetings as required or requested by the PI.• Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol. • Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document; case report forms (CRFs), enrollment logs, and drug accountability logs.Conduct of Research• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.• Collects documents needed to initiate the study and submit to the sponsor • Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals• Conducts or participates in the informed consent process.• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.• Coordinate participant tests and procedures.• Collect data as required by the protocol. Assure timely completion of Case Report Forms.• Maintain adequate inventory of study supplies. • Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures • Retains all study records in accordance with sponsor requirements and University policies and procedures.• Work with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Tunjukkan kurang

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  Clinical Research Malaysia

  Jul 2019 - now

  Study Coordinator