Chandraprabha Balachandran

●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 the trouble-free running of clinical trials
● Collecting data obtained from research, coding and analyzing it

●Administering neuro psychatric 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

• Manage the execution of the assigned clinical study (ies) from initiation through to closeout.
• Ensure that clinical study management and project deliverables are on time and is in accordance with SOPs, policies and practices.
• To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.
• To ensure the work is conducted as per SOPs, Policies and Good clinical practice's and applicable regulatory requirements.
• Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.
• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
• Review all reported Adverse Events (AEs) , Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
• Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial
• Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
• Review any other information as necessary to determine overall readiness of the patient information for next level review
  Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.Support in development and testing of data management system edit, data validation checks (diagnostics) and special listings / procedures used as tools for data review and discrepancy management activities
• Provide guidance and oversight to vendor partners
• Collaborates cross-functionally to resolve or escalate data management issues
• Collaborate with CRAs, Statistical Programmers, Biostatisticians, and project management team to meet data management deliverables and timelines for assigned clinical studies
• Participated in relevant operational meetings to identify and incorporate global operational issues into study design
• Validate data entry screens and edit check programs
• Support CTMS in coordination of receipt of all ancillary data e.g., safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock
• Organize electronic data loading, and generate manual queries in accordance with Standard Operating Procedures
• Review clinical trial data in accordance with global data management plans and applicable standardized data management processes to identify, missing, incomplete, or implausible data
• Interact with the dictionary coding and maintenance group to ensure appropriate process set-up
• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
• Apply quality control procedures and checks to ensure data quality standards are achieved.

· Monitoring and caring for patients in hospital

· Investigating, diagnosing and treating the health conditions of patients

· Prescribing and reviewing patients' medication

· Taking accurate notes, as a legal record and for other healthcare professionals to use

· Manage the entire operations of 30 bedded Healing Earth multi-specialty Ayurveda hospital and its sister concerns in India and abroad.

· Guided the entire process of Ayush empanelment and NABH Accreditation of the center.

· Involved in the process of initial and final assessment by QCHP of Remedy Ayurveda Center(Sister concern of Healing Earth Multi specialty Ayurveda Hospital) in Qatar

· ·Prepared various project for tie up with state government of Karnataka and implemented centers to cater public with aid from state government

· Complete planning and execution of new centers in Qatar

· Developing and upgrading the business plans and strategies for effective revenue generation of the hospital.

· Effectively handling a team of 50 members including consultants medical officers, nursing staff, front office executives, and paramedical staff

• Serve as the medical consultant in the planning, revision, implementation and evaluation of the health services
• Manage the day to day activities of the Health Centre including managing deployment and staffing
• Ensure thorough record keeping
• High standards of clinical care
• The identification of risks and detection of problems
• Coordinated with other healthcare providers to incorporate multiple aspects of clients' health into wellness plan.
• Developed care plans and agendas for clients based on individual health concerns and advised on specific diet and exercise plans.
• Tailored specific exercises and health plans to clients with physical and mental disabilities.