Parveen Thakran
Gurugram
Summary
Dynamic Central Monitor and Senior Assistant & Research Coordinator with a proven track record at IQVIA RDS India Pvt Ltd and Fortis Hospitals Limited. Excelled in database management and effective communication, enhancing project efficiency and team collaboration. Achieved significant improvements in clinical trial coordination and risk management, ensuring regulatory compliance and operational excellence.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Central Monitor
IQVIA RDS India Pvt Ltd
Gurugram
07.2021 - Current
- Attend study team meetings as needed or requested
- Contribute to the development and use of study management plans and/or DTE specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study
- Reported any suspicious activity or malfunctioning equipment to supervisors.
- Maintained database and regular logs of daily monitoring activities.
- Monitored the performance of systems and identified issues for resolution.
- Performed regular checks on equipment to ensure optimal working conditions.
- Ensured compliance with established guidelines for monitoring systems security protocols.
- Support project management team to develop monitoring strategy including monitoring triggers/thresholds
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
- Contribute to developing the study specific analytics strategy and/or work on developing advanced analytics
- With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections
- Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders
- Support CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan
- Manage project resources (CRAs/ CTAs/Centralized Monitoring team)
- Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.)
- Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies)
- In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data; performing the trend analytics for their respective study(ies)
- Participate in study team meetings/Project kick off meets and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items
- Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review
- Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
- Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
- Monitor site performance and make recommendations for timely corrective actions (eg.Telephone Contact or Triggered Onsite Monitoring Visit)
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
- Work in accordance of the Study Central Monitoring Plan
- Establish and maintain effective project/ site level communications with relevant stakeholders
- Maintain relevant project documents
- Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
- Attend Kick-Off meets, weekly team meets, and client meets, as per the project specific needs
Senior Assistant & Research Coordinator
Fortis Hospitals Limited
06.2019 - 07.2021
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
- Schedules study subject appointments and serves as the patient liaison to the PI and other participating physicians
- Reviews and comprehends each assigned protocol including study proceedings and timelines
- Working closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol
- Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed consent process
- Coordinates approval of new study agreements and contracts
- Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study close out visits
- Completes case report forms
- Extracts data from patient file (Source documents) in a timely manner
- Responds to data clarification requests in a timely manner
- May attend Investigator meetings requiring travel and report pertinent information back to research team members
- Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan
- Maintains records and other documentation of training
- Maintains subject screening logs and protocol deviation logs
- Maintains a excel sheet, tracking updates to database of all subjects enrolled on clinical trials
- Coordinates and facilitates monitoring and auditing visits
- Notifies appropriate institutional officials of external audits
- Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations
- Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis
- Ensures that all materials for each clinical trial protocol are available for subject enrollment
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data
- Performs specimen processing and shipment of biological specimen duties
- Assists with development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement
- Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research
Education
Master of Science - Clinical Research
Amity University
Gurgaon, India05.2019
Bachelor of Science - Medical Lab Technology
Amity University
Gurgaon, India05.2017
Skills
- Data analysis
- Database management
- Regulatory compliance
- Remote monitoring
- Trend analysis
- Clinical trial coordination
- Risk management
- Site management
- Effective communication
- Patient liaison
- Project management
- Team collaboration
- Incident reporting
- Coordination and teamwork
Countryofresidence
India
Languages
English, Fluent, Fluent, Fluent
Publications
- An Assessment Of Knowledge, Attitude, And Perception Of Pharmacovigilance Among Healthcare Professionals, Parveen Thakran & Dr Pramod Singh Khatri, British Journal of BioMedical Research, 2456-9739, 02, 05, 2018, 512-530, https://doi.org/10.24942/bjbmr.2018.338
- Primary central nervous system lymphoma(PCNSL), Parveen Thakran, British Journal of BioMedical Research, 2456-9739, 1, 04, 2017, 205-209, https://doi.org/10.24942/bjbmr.2017.169
- Paediatric Wilms Tumor: Contemporary Prognosis and Future Reflections, Dr Pramod Singh Khatri and Parveen Thakran, British Journal of Bio-Medical Research, 2456-9739, 1, 05, 2017, 241-246, https://doi.org/10.24942/bjbmr.2017.167
Jobtitle
Centralized Monitor
Clinicaltrialexperience - Therapeuticexperience
- Other, site coordinator and CM
- COVID-19, site coordinator and CM
- Gastrointestinal, Site Coordinator
- Crohn's Disease, Site Coordinator
- Ulcerative Colitis, Site Coordinator
- Hematology, Site Coordinator
- Neurology, Site Coordinator
- Rheumatology, Site coordinator
- Ophthalmology, Central Monitor
- Psychology, Central Monitor
Certification
- Communications Skills for Modern Management
- Excel formulas and functions quick tips
- Generative AI
- ICH-GCP & New drugs and clinical trials rules
Accomplishments
- Spotlight Awards 2023
- Bronze Award 2024
Languages
Hindi
First Language
English
Proficient (C2)
C2
Timeline
Central Monitor
IQVIA RDS India Pvt Ltd
07.2021 - Current
Senior Assistant & Research Coordinator
Fortis Hospitals Limited
06.2019 - 07.2021
Master of Science - Clinical Research
Amity University
Bachelor of Science - Medical Lab Technology
Amity University