Alphonsa Chacko
Instructor @Clinomic Center for Clinical Research Pvt. Ltd.
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WORK HISTORY
Instructor @Clinomic Center for Clinical Research Pvt. Ltd.
Kochi, IN
Design and deliver training programs in Clinical Research and Clinical TrialsProvide training on ICH-GCP and applicable regulations (CDSCO, FDA, EMA)Explain clinical trial phases, protocol development, informed consent, and ethical requirementsConduct training on CRF/eCRF, source documents, TMF, and essential trial documentationDeliver practical training in Clinical Data Management, Pharmacovigilance, and Quality AssuranceDevelop and maintain training materials and assessmentsEvaluate trainee performance and provide mentoring for job readinessEnsure training content remains aligned with current regulatory and industry standardsCoordinate with academic and corporate stakeholders for curriculum updates
EDUCATION
Cliniminds (Unit of Tenet Health Education Pvt Ltd )
Post Graduation Diploma , Clinical Data Management
Cliniminds (unit of Tenet Health Education Pvt Ltd)
Post Graduation Diploma, Clinical Research
Calicut University, Thenhipalem, Malapuram
Bachelor's degree, Biotechnology
Cliniminds (Unit of Tenet Health Education Pvt Ltd)
Post-graduation Diploma, Pharmacovigilance
Bharathiar University
Master's degree, Biotechnology
ABOUT ALPHONSA CHACKO
Certified Clinical Research Professional with 8+ years of experience across global clinical trials (Phases I–IV), specializing in clinical operations, pharmacovigilance, and clinical data management. I’ve worked closely with all stakeholders—from patients and investigators to CROs and sponsors—ensuring compliance and high-quality execution of trials.My experience spans end-to-end support, including site feasibility, site initiation (SIV), pre-study visits (PSV), close-out visits (COV), in-house CRA activities, and audit readiness. I’ve prepared and tracked essential documentation for monitoring visits and audits at both site and sponsor levels.I’m also experienced in site activation, including coordination of drug shipments, patient recruitment materials (translation, printing, logistics), and IRT system usage for randomization and supply management.Proficient in:CTMS: Veeva Vault, Oracle SiebelEDC: Medidata Rave, Veeva, SiebeleTMF: Veeva Vault, WingspanIRT/IWRS: Signant Health, EndpointPatient Training/Engagement: Advarra LongboatMy mission is to contribute to patient-centric, efficient, and compliant clinical research that drives meaningful outcomes in global healthcare.
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