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R.VIJAY R.N, M.Pharm
/, Kailash Colony, Anna Nagar Western Extension, Chennai . Tamilnadu, India. Mobile: + Email:
PROFESSIONAL SUMMARY: . years experience in Clinical Research with . years&; experience in Clinical Trial Monitoring as CRA/Sr.CRA.
EDUCATION/CREDENTIALS M.PharmPharmacology: J.S.S.College of Pharmacy, Ootacamund. PHASE EXPERIENCE: Phase Experience: Phase II and III global trials Therapeutic Areas: Type & Diabetes Mellitus DM, Ulcerative Colitis UC, Perennial Allergic Rhinitis PAR, Oncology and Antibiotic Associated Diarrhea AAD. TECHNICAL SKILLS: Clinical Trial Monitoring, Project Management, Site and Vendor Management, Mentoring, Budget Negotiations and Data Management. CAREER HISTORY Senior Clinical Research Associate I/Team Lead Dec Till date Vanta Bioscience, Division of Kemin Industries South Asia Pvt Ltd, Chennai. Erstwhile Kemin Pharma Team lead in ulcerative colitis and perennial allergic rhinitis study in Malaysia and Ukraine. Led team in phase clinical trial in ulcerative colitis with enrolled subjects in India. Led and executed the study startup activities in AAD clinical trial for sites in India. Led a dynamic team of Clinical Research Associate&;s in UC, PAR and AAD studies. Liaison with CRO in Malaysia and Ukraine for the conduct PAR and UC clinical trials. CoMonitored with CRO for sites in Malaysia for the perennial allergic rhinitis study. Liaising with central laboratories for the conduct of trials in India, Malaysia and Ukraine. Establish oracle clinical database live with data management for the UC and PAR trials. Assisted Project Manager PM in preparation of budgets, contracts, project communication plan, monitoring plan, monitoring tools and project trackers.
Assisted the team in the development of study documents, SAE, CRF and other applicable guidelines. Assisted PM and team in the conduct of Investigator Meeting IM in Turkey and Malaysia for PAR and UC trials. Audited CRO and central laboratory in Kulalumpur, Malaysia for the PAR clinical trial. Implemented innovative tracking tools and trackers for management of trials in Kemin. Participated in revision of SOP&;s and implemented monitoring checklists, logs and forms. Mentored CRA&;s in effective monitoring, documentation and site management. Reviewed trip reports and updated PM the status of trials in India, Malaysia and Ukraine. Performed Investigator identification, Feasibilities, Site Selection Visits SSV, Initiation Visits, Monitoring Visits and Close Out Visits. Prepared and finalized reports with PM. Effectively monitored and performed source data verification SDV at sites for the UC clinical trial in India. Monitoring encompassed ICF, Source & CRF verification, IP accountability, AE & SAE reporting, lab report verification and Reconciliation of TMF. Conduct weekly project team & CRO meetings for trial in India, Malaysia and Ukraine. Process investigator and vendor payments in consonance with agreement milestones. Project tracking included recruitment, monitoring visits, CRF, DCF&;s and payments. Participate in development committee meetings and update management the trial status. Liaison with KOL&;s for protocol developments, study conduct and investigator meetings. Liaison with CRO in monitoring and close out activities for the UC study in Singapore. Communicated with SMO for regulatory and ethics committee submission in Srilanka.
CLINICAL RESEARCH ASSOCIATE DiagnoSearch Life Sciences Pvt Ltd, Mumbai Erstwhile iGATE Clinical Research Int Pvt Ltd Oct to Dec
Initiated and monitored centers in the core and extension studies of type diabetes mellitus DM. Was involved in study start up activities and initiated site in the oncology trial in India. Assisted PM/Team in the preparation of the investigator meeting for type DM trial. Identified Investigators, performed CDA&;s, feasibilities, SSV for the type DM trial. Liaison with translating agencies for translation and finalization of study documents. Performed ethics committee submissions in accordance to the timelines. Monitored and performed source data verification of subject source documents & TMF. Monitored eCRF and assisted the sites in timely resolution of data management queries. Prepared and finalized reports with project manager and submitted to sponsor in time. Proactively coordinated with sites and vendors for timely resolution of issues. Faced independent sponsor audit at sites and internal QA audit at sites in the type diabetes mellitus study with no major findings observed. Received sponsor appreciation for effective monitoring and site management in DM trial. Performed comonitoring visits and assisted team members in the source data verification and closure of queries for database lock at other centers in type diabetes mellitus trial.
As a project assistant handled sites and faced independent audit of inhouse TMF files in type DM trial. CoMonitored with Sr.CRA&;s and performed source data verification in Type DM trial. Responsibilities included weekly updation of project trackers, CRF query status, EC submissions, TMF reconciliation, and reporting to client in type DM trial. Maintained and shipped documents to central file maintenance department in CRO.
DATA ANALYST Cognizant Technology Solutions Pvt Ltd, Mumbai Jan to Sep
Retrieved SAE listings from Oracle Clinical and Safety Database for oncology trials. Performed reconciliation of SAE&;s Demography and TACO events as per ICHEA. Documented SAE&;s and raised queries through DCF&;s to Investigators for resolution. Created protocol specific edit checks, selfevident corrections and CRF completion guidelines in Parkinson disease and multiple sclerosis trial. Created clean and dirty patient datas, tested and validated oracle clinical database. Discrepancy management. Therapeutic Areas: Phase Parkinsonism, Multiple Sclerosis and Oncology studies
OTHER EXPERIENCES Teaching facultyQuest Training and Research Institute, Bangalore Oct to Dec Senior Research FellowTIFAC, Ootacamund May to Sep Medical RepresentativeGlaxoSmithKline Pharmaceuticals, Trivandrum Jan to Jun INVESTIGATOR MEETINGS/TRAININGS Trained in ICHGCP and inhouse SOP&;s of Kemin Pharma and Diagnosearch Life Sciences Pvt Ltd. Assisted project manager and coordinated with CRO for the conduct of the investigator meeting at Istanbul, Turkey in perennial allergic rhinitis on Nov. Assisted project manager and CRO for the conduct of the investigator meeting at Kualalumpur, Malaysia for clinical trial in PAR on Nov. Presented ICHGCP Investigator Responsibilities in IM at Kualalumpur and Istanbul. Attended IM in Type Diabetes Mellitus conducted in Berlin, Germany from May to May. Attended the IM in Type diabetes global trial in Goa from Jul to Jul. Attended the IM in Hepatitis C global trial in Mumbai on Feb.
DATABASE AND COMPUTER PROFICIENCY Well versed in the applications of MS Project, Word, Excel and PowerPoint. Hands on experience in eCRF monitoring Inform ., etrials and datalabs, Oracle ClinicalCRF database, IVRS, IWRS, eECG transmission and paper CRF.
Proficient in Safety DatabaseSAE Specific ArisG, Argus.
ACHIEVEMENTS AND AWARDS Recipient of "Best Learner Award" in "Entero Plus" division during training in GlaxoSmithKline Pharmaceuticals Pvt Ltd in Mumbai in Jan . Winner in Intracollegiate table tennis championship conducted in JSS college of Pharmacy, Ootacamund, Tamilnadu, India & . Winner and received best player award in the State level inter pharmacy college table championship held in J.S.S.College of Pharmacy, Ootacamund, Tamilnadu, India during May .
PERSONAL DETAILS LINGUISTIC FLUENCY: Fluent in speaking and writing English, Tamil, French Basic and Hindi. Fluent in speaking Malayalam. NATIONALITY: Indian FATHER&;S NAME: Mr.R. DATE OF BIRTH: Feb PASSPORT: Hold a valid Indian passport valid till Oct VISA: Hold a valid Multiple Entry Malaysian Visa till Nov . DRIVING LICENSE: Hold a valid Car Driving License.