
Timeline
About me
Clinical Project Coordinator @ Alimentiv | Project Management, Clinical Trials
Education

Al shifa college of pharmacy, perinthalmanna
2012 - 2018Doctor of pharmacy pharmacy
Conestoga college
2020 - 2021Healthcare administration and service management health/health care administration/management
Experience

Kims alshifa super specialty hospital
Aug 2017 - Sept 2018• Assisted in protocol development, IEC (Institutional Ethics Committee) approval process and clinical documentation and retrospective chart review.• Reviewed and identified potential subject files, educated subjects about project (benefits and risk), collected informed consent forms and enrolled subjects to academic projects.• Carried out experiments and research according to protocols laid out by primary researchers in the department of Nephrology, Psychiatry and Gastroenterology.• Collected, analyzed, entered data, and maintained data to electronic data base and updated existing databases.• Conducted literature search, wrote literature review, and carried out meta-analysis for supporting the research project.• Collected and logged experimental data of each epidemiological study.• Conducted statistical analyses of patient data sets of studies.• Published three research articles post-completion of studies based on scientific expertise and data analytics. Show less • Monitored, assessed causality, and reported Adverse Drug Reactions to the hospital pharmacovigilance department.• Active member of hospital Drug Information Centre (DIC).• Counseled patients regarding medications, diagnosis, and lifestyle modifications required and dispensed medication as per prescriptions.• Assisted in conducting and publishing two academic research in the department of Nephrology.• Conducted and published a one-year research study in the Department of Gastroenterology and Psychiatry. Show less
Research Assistant
Aug 2017 - Sept 2018Clinical Pharmacist
Aug 2017 - Aug 2018

Fortis hospitals
Jan 2018 - Mar 2018Clinical specialist- Identification and reporting of ADRs- Monitoring Drug Interactions- Dose calculations, patient counseling, and Patient-specific dosing adjustments in the department Hemato-oncology, Neurology and Gynecology- Discuss with clinician/health professional to provide better patient care and therapeutic interventions

Iqvia asia pacific
Jan 2019 - Feb 2020Drug safety associate• Processed Individual Case Safety Report (ICSR) including spontaneous, solicited, literature and clinical trial Adverse Drug Reaction (ADR) reports as per applicable regulations, guidelines, Standard Operating Procedures (SOPs), and project requirements.• Coded relevant case data in including but not limited to medical and medication history, suspect and concomitant drugs, indications, laboratory data, and suspected events using an appropriate dictionary (MedDRA, Company Product Dictionary, WHO-DD).• Wrote case narratives and entered data as per drug safety regulations, including GVP, FDA, ICH-GCP, GADPR, and internal SOP’s, and generated queries pertinent to the cases.• Assessed seriousness, causality, and expectedness of cases at both event and case levels. Conducted quality review, assisted with reconciliation and ICSRs closures.• Addressed e-mails and query follow-ups in the clinical trial projects with CRAs (Clinical Research Associate), clinical project managers, and various sites worldwide, supporting ICSRs activities within timelines. Show less

Walmart
Jan 2021 - Jan 2022E-commerce customer fulfilment associate
Alimentiv
Feb 2022 - nowClinical project coordinator• Provides administrative support to project teams, business leads, and stakeholders in different Phase 1 double-blinded randomized trials in IBD.• Coordinate the flow of documents and resources for project meetings. Schedule, prepare agendas and minutes for internal, sponsor and safety review committee meetings.• Assist CRAs, Project Manager, and Project Director in processing various trial-related documents and filing them in eTMF (Box / Veeva Vault).• Assist Project Management in maintain timelines and trackers in SmartSheet. • Maintain site, study, screening, and subject information in CTMS and develop Sponsor-facing trackers. Managing, Maintaining, and Monitoring site, sponsor, and internal team access to different vendor systems like Cerba Trova, GXP, IBM Clinical, etc. • Oversee project materials, equipment, and supplies, ensuring all activity is entered/recorded, tracked, monitored, and revised in accordance with protocols and regulatory guidelines. • Prepared and distributed Newsletters and Newblasts to site staff and maintained site personnels in different vendor systems.• Initiated training requests and monitored the progress of training for team members.Process site information sheets and translation requests and assist in developing and maintaining ISF binders. Show less
Licenses & Certifications

Pharmacist
Kerala state pharmacy councilJan 2019- View certificate

Project management simplified
LinkedinOct 2021 - View certificate

Clinical trial agreements (ctas)
Citi programDec 2022 - View certificate

Tcps 2: core
Government of canadaAug 2022 - View certificate

Project management foundations
LinkedinSept 2021 
Cpr/aed/first aid
Canadian red crossDec 2020- View certificate

Hipaa for education and research
Citi programDec 2024 
Conducting research in a post-pandemic world
LinkedinJan 2023- View certificate

Excel basics for data analysis
CourseraFeb 2025 - View certificate

Ich e6(r3): an introduction
Citi programJul 2025
Volunteer Experience
Health Educator
Issued by NSS
Associated with Athira Elezabath George
Languages
- enEnglish
- hiHindi
- maMalayalam
- taTamil
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