Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Personal Information
Therapeutic Experience
Publications
Disclaimer
Timeline
Generic

Ashish Thomas Abraham

Bangalore

Summary

A dynamic professional with 10+ years' experience in Clinical Research. Extensive experience in Diabetes, Renal, Cardiovascular, Hematology, Oncology, Gastroenterology therapeutic indications and picks up new procedures quickly. Offering advanced planning, problem-solving and communication skills. Currently aspiring for project management roles. In his current organization is responsible as a Regional Project Lead across multiple Projects. He had a unique opportunities to act as country lead in post close out activities.

Overview

10
10
years of professional experience

Work History

Senior Clinical Research Associate II

PSI-CRO Pharma India Pvt Ltd
09.2022 - Current
  • Project management tasks at a country/regional level, in the capacity of Lead Monitor
  • Coordinates investigator/site identification process, including post-award feasibility, startup processes, reviews and approves IP release documentations and site regulatory packages
  • Monitors project timelines and patient enrollment, and implements respective corrective and preventive measures, including timely implementation of enrollment boosting measures
  • Review of monitoring visit reports for all visit types and supports Monitors with query resolution process, including Central Monitoring observations
  • Coordinates and monitors an adequate safety information flow and protocol deviation reporting
  • Coordinates and monitors clinical supplies management and ensures study-specific and corporate tracking systems are maintained in a timely manner and kept up-to-date
  • Acts as the main communication line between Monitor and Regional Lead or Project Manager
  • Conducts study-specific Co-Monitoring visits
  • Supports the Monitor with budget and contract negotiation with the site and ensures timely and correct invoicing and payment of sites/investigators
  • Leads project team calls on a country level and provides status updates/reports to Regional Lead/Project Manager.
  • Improved clinical trial efficiency by streamlining data collection and management processes.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.

Senior Clinical Research Associate I

PSI-CRO Pharma India Pvt Ltd
07.2021 - 08.2022
  • Ongoing evaluation of quality (data integrity and compliance) at a site and/or country regional level, through report reviews, co-monitoring, onsite and in-house training, etc
  • Conduct site audit preparation visits and resolve site audit findings and participate in study site audits and other types of QC visits
  • Supports project team in preparation for study audits, resolution of audit findings, and preparing audit responses on a country/regional level, as applicable
  • Supports project team in CAPA development and implementation
  • Conduct field assessment visits, following appropriate training and authorization from the Line Manager
  • Mentoring of monitors and conducting field training after authorization from the Line Manager.

Clinical Research Associate II

PSI-CRO Pharma India Pvt Ltd
08.2018 - 06.2021
  • Acts as the mainline of communication between the sponsor and the site
  • Builds and maintains good rapport with the site staff involved in the conduct of the study
  • Prepares, conducts and reports site selection, initiation, routine monitoring and close-out visits
  • Monitors patient enrollment to ensure recruitment targets and project timelines are met at site level
  • Maintains study-specific and corporate tracking systems at site level
  • Ensures accurate and timely reporting and follow up of Adverse Events (AE)/ Serious Adverse Events (SAE) and protocol deviations
  • Performs source data verification and follows up on data queries
  • Ensures proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
  • Reviews the status and contents of essential documentation and reconciles study site file at site level
  • Facilitates the flow of documents and laboratory supplies between the site and the Central/Regional Lab/Central Reviewer
  • Supports preparation of draft regulatory and ethics committee submission packages, where applicable
  • Facilitates site budget and contract negotiations, where applicable
  • Manages investigator site payments, where applicable
  • Conducts project-specific training of investigators
  • Ensures ongoing evaluation of quality (data integrity and compliance) at a site level
  • May conduct site audit preparation visits and resolve site audit findings
  • Participates in study site audits and client onsite visits, as required
  • Monitoring experience in India, Singapore, and Malaysia.

Clinical Research Associate

George Clinical India Pvt Ltd
04.2016 - 07.2018
  • Ensure that rights and wellbeing of a research participant is protected throughout the duration of the study
  • Perform Initiation, Monitoring, and close out visits
  • Assisting in the preparation, handling and tracking of the Ethics committee submissions
  • Safe and proper conduct of studies
  • Entering data into electronic data capture system
  • Tracking protocol deviations, adverse events and study materials on site
  • Coordinating investigational product accountability periodically with all clinical research coordinators from all the sites
  • Ensure and maintain inventory of Study consumables at each site
  • Act as the main line of communication between Investigator, sponsor and CRO in study conduct activities
  • Involved in post closeout activities of a major long term study as country leads for Final TMF reconciliation, Payment reconciliation, Medical reimbursement of subject SAEs, FDF collection, CSR distribution, etc.

Clinical Process Associate 2

Quintiles Transnational
01.2015 - 04.2016
  • Assist with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
  • Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and SOP
  • Assist with periodic review of study files for completeness
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
  • Assist with the tracking and management of CRFs, queries and clinical data flow
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
  • Perform assigned administrative tasks to support team members with clinical trial execution
  • Remote Monitoring: Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency and correctness of the data
  • Communicate any observations, protocol deviation tracking, safety alerts, quality issues, trends/patterns, risk factors, etc
  • That may affect the planned conduct of the trial to the clinical team and local CRO/directly to the site for timely follow-up of actions and issue resolution
  • Perform data query resolution process (with site, CRO, CRA, and DM)
  • Update Clinical Trial Management System (CTMS) or other study management systems as per requirements
  • Responsible for developing trial-specific tools (i-site packs for CRA, Biweekly reports for clinical team meeting)
  • Acts as a close partner with the local CRO, CRAs, and Trial Team
  • Interact with DM/programming group to ensure that efficient tracking and data reports are generated as required with flags and relevant deviation alerts
  • Support Trial Manager/Lead for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks factors, etc
  • That may affect the planned conduct of the trial to the clinical team and local CRO/directly to the site for timely follow-up of actions and issue resolution
  • Development of Detailed Study Proposals on how the department can support the trail team
  • Conducting Training Sessions for e-TMF Review, Investigator Payments review, Safety letter cascading and tracking, Vendor Management.

Clinical Research Coordinator

SMO Connect India Private Limited
10.2013 - 01.2015
  • Site Selection/Management, Site-staff training, assisting, monitoring and study closeout
  • Ensure overall adherence of FDA, GCP, Schedule Y and ICH guidelines
  • Clinical trial agreement/investigator financial agreement assistance
  • Conducted monitoring visits for sites in accordance with the agreed schedule
  • Maintained regular communication with designated sites, ensuring adequate information flow between company and the site staff
  • Co-ordination with Central lab, Drug safety and Data management department's
  • Establishment and maintenance of project timeline including recruiting, start-up, monitoring, and close-out of sites
  • Adverse event evaluation and reporting within specified timelines
  • Reviewing the CIOMS/Schedule Y documents and coordinating with the sites for resolving the queries both in-house and at site if any
  • Tracking of the CIOMS reports for all sites
  • Review of protocol and ICF and providing operational inputs
  • Ensured that the investigators and site staff are aware of and comply with the study protocol, procedures and SOPs, GCP and other regulatory requirements.

Education

Certification - Clinical Research & Regulatory Affairs

Clinbiotech
12.2012

Graduate Certificate - Science and Technology (Food Technology)

Massey University
12.2012

Bachelor of Technology - Biotechnology

Karunya University
05.2010

Skills

  • Clinical Trail Management and Site Management
  • Good understanding of GCP (ICH and Schedule Y)
  • Ability to work in teams and individually
  • ICH GCP certification (Barnett Educational Services)
  • Quick learning of different trades
  • Strong communication skills
  • Advanced Level computer skills in EXCEL and Word
  • Managerial skills and interactive skills with customer
  • Systems Like CTMS, eCRF like INFORM, EDC, RAVE, CLINPHONE, ALMAC, ELVIS(eTMF), Vera Vault (v-TMF), Suvoda, Xellerate
  • Strong Analytical skills
  • Coordinating site operations
  • Completing regulatory documents
  • Vendor Management Experience
  • Action planning
  • Site monitoring expertise

Accomplishments

  • Secured second place for the poster "Synthesis and Characterization of ZnO Nanoparticles" during the National Seminar on "Recent perspectives in Nanotechnology" on 01/22/2010 at the Department of Biotechnology & Microbiology, Hindustan College of Arts and Science, Coimbatore.
  • Summer Training Program in "Modern Techniques in Cancer Research" at Regional Cancer Centre, Trivandrum.
  • Certificate of Excellence by SMO CONNECT for outstanding performance and lasting contribution to the company.
  • Quintiles WWD award for successfully streamlining process for execution for GDN team for the diabetes study (06/2015).
  • Quintiles WWD award for Successfully completion and long service with quality form Regional CPM for GDN team for the diabetes study (02/2016).
  • George Clinical Performance Award (GARP awards) for excellent performance and quality delivery (06/2017).
  • Completed the Oncology program for monitors Conducted by the PSI trainer master's Group on 12/18/2020.
  • Completed "Radiopharmaceuticals for Monitors program" Conducted by the PSI trainer master's Group on 07/09/2021.
  • Completed "Hematology for Monitors Course:" Conducted by the PSI trainer master's Group on 04/06/2022.
  • Completed "Gastrointestinal Disorders for Monitors" Conducted by the PSI trainer master's Group on 12/22/2022.

Languages

English
Hindi
Malayalam

Personal Information

  • Age: 34
  • Father's Name: Mr. Thomas Abraham
  • Date of Birth: 01/14/88
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Therapeutic Experience

  • Endocrinology, Dyslipidemia, III, 3, Monitor
  • Cardiology, Cardiovascular disease, III, 4, Monitor
  • Endocrinology, Type 2 diabetes mellitus, III, 2, Monitor
  • Pulmonology, Chronic obstructive pulmonary disease, III, 2, Monitor
  • Oncology, Non-Small Cell lung Cancer, III, 1, Monitor
  • Immune System Disorders, Lupus Nephritis, III, 27, Remote Monitor
  • Inflammatory disorder, Rheumatoid arthritis, III, TMF Reviewer
  • Endocrinology, Type 2 diabetes mellitus with Cardiovascular and Renal Outcome, IV, 18, Remote Monitor, Site payments and Vendor management
  • Endocrinology, Type 2 diabetes mellitus with Cardiovascular, III, 8, Monitor
  • Endocrinology, Type 2 diabetes mellitus with Renal Outcome, III, 4, Monitor
  • Nephrology, Chronic Kidney Disease, III, 4, Feasibility Clinical Research Associate
  • Hematology, Bleeding disorders, I/II, 5, Monitor
  • Hematology, Relapsed or Refractory DLBCL, I/II, 3, Feasibility Clinical Research Associate
  • Oncology, Endometrial cancer, II, 4, Monitor
  • Oncology, Multiple solid tumors with specific mutations, II, 2, Monitor
  • Oncology, HER-2 positive breast cancer, III, 8, Monitor
  • Hematology, Paroxysmal nocturnal hemoglobinuria, III, 1, Monitor
  • Gastroenterology, Ulcerative colitis, II/III, 10, Feasibility Clinical Research Associate
  • Radiopharmaceutical Oncology, Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin, III, 3, Monitor
  • Gastroenterology, Ulcerative colitis, II, 6, Lead Monitor
  • Gastroenterology, Crohn's Disease, III, 14, Lead Monitor
  • Gastroentrerology, Ulcerative colitis, II, 8, Lead Monitor
  • Gastroenterology, Crohn's Disease, II, 4, Lead Monitor

Publications

(2012).M. Sevanan, P. M. Narayanan,Wijo Samuel Wilson, Ashish Thomas Abraham. Synthesis, Characterization, and Antimicrobial Activity of Zinc Oxide Nanoparticles against Human Pathogens. BioNanoScience, 1.

Disclaimer

I declare that the above information is true to the best of my knowledge.

Timeline

Senior Clinical Research Associate II

PSI-CRO Pharma India Pvt Ltd
09.2022 - Current

Senior Clinical Research Associate I

PSI-CRO Pharma India Pvt Ltd
07.2021 - 08.2022

Clinical Research Associate II

PSI-CRO Pharma India Pvt Ltd
08.2018 - 06.2021

Clinical Research Associate

George Clinical India Pvt Ltd
04.2016 - 07.2018

Clinical Process Associate 2

Quintiles Transnational
01.2015 - 04.2016

Clinical Research Coordinator

SMO Connect India Private Limited
10.2013 - 01.2015

Certification - Clinical Research & Regulatory Affairs

Clinbiotech

Graduate Certificate - Science and Technology (Food Technology)

Massey University

Bachelor of Technology - Biotechnology

Karunya University

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Ashish Thomas Abraham