A clinical/biomedical researcher with a diverse background of Biotechnology/ Life sciences/ Rehabilitation/ Neuroscience/ Microbiology/ R&D/Animal model/ Cognition/ Motor control&Coordination/ Brain stimulation/Molecular biological experience.
Clinical study officer
Since April 2015
Expertise: *Assume overall responsibility for the preparation of protocols and Case Report Forms, finalisation of monitoring and data management options (either in-house or contracted to a Contract Research Organisation), Ethics committee approval, development of recruitment strategies to increase patient randomisation into the trial, the provision of clinical trial materials, and management of the trial. *Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development *Coaching of CRAs in various aspects of clinical trial management *Ensure the smooth running of the clinical trial by developing tools to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management. *Management of Academic/Phase II/Phase III clinical trials and TMF organization of the clinical trial
Since April 2011
My doctoral research is about, "The effect of Non invasive brain stimulation therapies on neurodegenerative population and healthy individuals" Skills: Planning and Setting up an scientific research in an effective manner (clinical and biomedical), Screening and recruiting patients, Conducting good literature survey, Standardization/Optimization/Troubleshooting skills, Acquisition of data and analyzing it, Presenting scientific research in international conferences, Writing scientific research (publications),Reviewing scientific research, Coaching students for their thesis project (Bachelors and Masters), Have working experience in various environments ( Research & Development company/ Hospital/ Universities). Expertise: Management of academic/non-academic clinical trials Planning,scheduling and executing clinical trials GCP guidelines Patient recruitment Protocol formation Genotyping several genes from the body fluids Behavioral experiments in healthy rodents Brain stimulation experiments in animal models of neurodegenerative diseases investigating the mode of action/underlying mechanisms.
January 2009 --- January 2010
worked in screening of drugs (supplements for skin care and energy enrichment products) for its anti-oxidative properties in "Human fibroblast skin cells"
January 2008 --- January 2009
Investigated the anti-inflammatory properties of the drug "costunolide" on Meurine Microglia-BV-2 cell lines
Analytical thinkingAttention to detailCommunicativeFlexibilityCoordination
Clinical Data Management (CDM)Clinical researchClinical study reportsClinical Trial Management System (CTMS)Clinical trialsGood Clinical Practice (GCP)Phases of clinical development (phase I to IV)Principles and ethics of clinical research
Skills and Expertise
Patient recruitmentEthics committee submissionsComplete case report form (CRF)Verify data
coordinating research projectsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Execute scientific projectsFollow up projectsproject managementPublish scientific projectsSet up research projects Monitor a clinical study Develop clinical trial protocolsClinical data collectionCoach clinical staffCreate clinical documentsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Monitor Key Performance Indicators (KPI's)Review monitoring reportsSupervise clinical monitorsInteract with CROs
Master's degree in Biotechnology from Holy Cross College,Trichy in 2009
Bachelor of Science (B.Sc.) in Microbiology, General from St.Mary`s College,Tuticorine in 2007
Training and Certification
Academic writing and presentation skills Certification
Biomedical writing course Certification
Lab animal handeling Certification
Lab animal handeling-FELASA C Certification
Scientific writing and speaking for public Certification