Chandra Balachandran
Exton,United States
Summary
Clinical research professional with extensive expertise in study operations, risk-based monitoring, and data management (SCDM certified clinical data manager). Proven track record of enhancing data accuracy and improving patient safety. SOCRA certified with strong leadership capabilities, dedicated to streamlining operations and ensuring regulatory compliance.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator /Clinical Research Coordinator lll
Lankenau Institute for Medical Research
Wynnewood, United States
01.2024 - Current
- Conducted study visits, adhering to ICH/GCP and FDA clinical research protocols.
- Database design and implementation for clinical research projects, ensuring compliance with regulatory standards.
- Implemented stringent quality control measures, reducing data entry errors throughout study lifecycle.
- Monitored patient safety during trials, promptly documenting and reporting adverse events.
- Managed patient recruitment and informed consent processes to meet trial objectives.
- Coordinated clinical trial activities with healthcare professionals to enhance data accuracy.
- Maintained accurate case report forms and source documents for comprehensive traceability.
- Streamlined patient visit schedules, reducing wait times and improving retention rates.
Clinical Research Coordinator
Dr.Brian Abaluck Sleep Medicine
Malvern, PA
03.2023 - 01.2024
- Maintain ISF: training documentation, filing notes from sponsors/CRO's and IRB requirements.
- Primary responsibility for IRB interactions.
- Maintain budget including invoicing and reconciliation of payment.
- Host audits, Site Initiation Visits, Site Monitoring Visits and Close Out Visits.
- Address protocol deviations and adverse events.
- Overseeing trouble-free running of clinical trials.
- Collecting data obtained from research, coding and analyzing it.
- Administering neuro psychiatric scales( CDR,GDS, C-SSRS, MMSE,ADAS Cog, ADCS-ADL,NPI,ZBI).
- Managing budgets set aside for research.
- Communicating with participants regarding study objectives.
- Administering questionnaires and monitoring participants to ensure they are compliant.
- Liaising with laboratories regarding research findings.
- Monitoring the study to ensure that it complies with protocols, is ethically-conducted and follows regulatory standards.
- Maintaining research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines.
- Collection, labeling, storage and transport of all specimens.
- Making sure that all equipment and supplies needed for the study are in-stock and in good working order.
Clinical Research Associate(Centralized Monitor)
IQVIA
Bangalore, Karnataka
03.2021 - 10.2022
- Directed clinical study execution from initiation to closeout, ensuring timely deliverables compliance.
- Identified and verified anomalies in patient-reported data with clinical sites for accuracy.
- Supported multiple projects by reviewing structured clinical data outputs effectively.
- Reviewed inclusion and exclusion criteria to confirm patient eligibility accurately.
- Analyzed dosing records for investigation product protocol adherence and dosage precision.
- Validated supporting information accuracy by reviewing reported AEs and medical history.
- Collaborated cross-functionally to resolve data management issues and meet project timelines.
Operations Manager
Healing Earth Multispecialty Hospital
Bangalore, Karnataka
10.2015 - 02.2020
- Ensured compliance with healthcare regulations and standards throughout operations.
- Supervised day-to-day workflow of employees in order to maximize productivity and maintain quality standards.
- Built strong operational teams to meet process and production demands.
- Managed daily operations of patient care services in a multispecialty environment.
- Coordinated staff schedules to ensure optimal coverage across all departments.
- Oversaw supply chain management to maintain adequate inventory levels for medical supplies.
- Developed and implemented operational policies to enhance workflow efficiency.
- Led training sessions for new staff on hospital procedures and protocols.
- Collaborated with department heads to improve service delivery and patient satisfaction.
- Evaluated operational processes and identified areas for improvement within the hospital system.
Education
Advanced Diploma - Clinical Data Management
Bangalore Clinical Research Institute
Bangalore02.2023
MBA - Health Care Management
Sikkim Manipal University
Sikkim01.2014
Bachelor of Science - Alternative And Complementary Medicine And Medical Systems
Vishnu Ayurveda Medical College
Kerala01.2012
Skills
- SOCRA certified clinical research professional
- SCDM certified clinical data manager
- GCP certification
- IATA certification
- Rave EDC certification
- Risk-based monitoring
- CRF review and discrepancy management
- Clinical trial phases I, II, and III
- Dictionary coding MEDRA 231
- Medidata Rave and Oracle Clinical
Certification
• SCDM Certified Clinical Data Manager
• SOCRA Certified Clinical Research Professional (CCRP Certification)
• Advance Diploma in Clinical research (Pharmacovigilance + Clinical data management)
• GCP (Good Clinical Practice Course - US FDA Focus) Certification
• Shipping and transportation of regulated Biological material (CITI Program)
• Financial conflict of Interest (CITI Program)
• Group 1 Biomedical Research Investigators and Key Personnel (CITI Program)
• CDR Rater certification (Washington University)
• Design and Interpretation of Clinical Trials (John Hopkins University)
• Certification in Clinical data management
• Microsoft Excel Essential training
• Clinical data science
• SOCRA Certified Clinical Research Professional (CCRP Certification)
• Advance Diploma in Clinical research (Pharmacovigilance + Clinical data management)
• GCP (Good Clinical Practice Course - US FDA Focus) Certification
• Shipping and transportation of regulated Biological material (CITI Program)
• Financial conflict of Interest (CITI Program)
• Group 1 Biomedical Research Investigators and Key Personnel (CITI Program)
• CDR Rater certification (Washington University)
• Design and Interpretation of Clinical Trials (John Hopkins University)
• Certification in Clinical data management
• Microsoft Excel Essential training
• Clinical data science
Timeline
Lead Clinical Research Coordinator /Clinical Research Coordinator lll
Lankenau Institute for Medical Research
01.2024 - Current
Clinical Research Coordinator
Dr.Brian Abaluck Sleep Medicine
03.2023 - 01.2024
Clinical Research Associate(Centralized Monitor)
IQVIA
03.2021 - 10.2022
Operations Manager
Healing Earth Multispecialty Hospital
10.2015 - 02.2020
Advanced Diploma - Clinical Data Management
Bangalore Clinical Research Institute
MBA - Health Care Management
Sikkim Manipal University
Bachelor of Science - Alternative And Complementary Medicine And Medical Systems
Vishnu Ayurveda Medical College