Dr. Ananya Bhosale

I'm Dr. Ananya having 11+ years in Medical Field [5 years as a Clinical Research Coordinator]

 Education - BHMS with Diploma in Clinical Research and certified courses such as CGO, DNYS and CSD 

Skills - Trial Master File, Clinical Study Reports (CSRs), Data Management, Investigator's Brochures (IBs) eCRF documentation, Analytics, Study Protocols Understanding, DCF handling, SAE Reporting, Accountability, IP management, Handling Temperature Exertion Issues, Facing NABH and EC Audits, Collection of the Subject’s Diagnosed History & Management of Essential Documents, etc.

I] Sahyadri Clinical Research & Development Center, Pune Jan 2020 — Present
(A Unit of Sahyadri Hospitals Limited)
Clinical Research Coordinator
● To work as a clinical coordinator in various clinical research trials.
● To maintain reports and related documentation or the activities undertaken.
● Overseeing smooth functioning of clinical trials.
● Collecting and documenting data obtained from Clinical Research.
● Monitoring research subjects to ensure adherence to study protocol.
● Adhering to Research and Regulatory standards.
● Issue Deviation and work on Corrective Actions and Preventive Actions (CAPA)
● Defended Audits of the Ethics Committee and NABH with no major findings.
● Maintaining detailed records of studies as per DCGI / CDSCO, and ICMR guidelines.
● Assisting in subject recruitment.
● Ensuring necessary supplies and equipment for a study are in stock and working order.
● Coordinate with PI, Sponsor, and Monitors for smooth functioning of Clinical Trials.
● Handled SAE for Hematology and Oncology trials as per the SUGAM portal and maintained timelines
Key Accountabilities:
Led patient recruitment efforts for clinical trials focused on Hematology and Oncology.
Drove 100% compliance for clinical trials as measured by third-party auditors by aligning operational activities to study protocols. Collaborated with third-party organizations to coordinate pickup and delivery of hazardous materials, achieving 100% compliance with safety standards set for the by regulating entities.
Planned and independently managed 11 concurrently running Hematology and 7 Oncology trials. Responsible for all operational aspects of clinical trial oversight including the delivery of study on time, within budget and scope, and in compliance with GCPs, SOPs, and standards. Managed multiple teams of physicians, patients, and research partners.
Developed and implemented patient recruitment plans to ensure trial success. Earned 80% patient retention and satisfaction rating by proactively evaluating and relaying vital information and resolving patient issues.

II] Inamdar Multispeciality Hospital, Pune Jul 2012 — Jul 2013
Clinical Research Coordinator
● Initiate, manage, and monitor clinical research projects and provide project-specific administrative support.
● Coordination and management with the Ethics Committee for clinical trials.
● Schedule and participate in monitoring and auditing activities.
● Updated case reports and source documents for clinical trials, arranged study interviews and recruitment.
● Conduct independent study coordination and screen potential patients for protocol eligibility.
● Administer surveys to study participants as directed.

III] Bhosale Clinic, Pune (Self-Employed) Aug 2013 — Jan 2020
General Practitioner
● Dealing with patient complaints about the quality of service of the practice.
● Keeping up to date with the latest treatments, medicines, and medical developments.
IV] Tara Homoeopathic Clinic, Mumbai Sep 2011 — May 2012
Homeopathic Practitioner
● Perform preliminary examination of patients and diagnose the nature of the medical condition they are suffering from.
● Treatments are given for various hair issues.

I] Professional Diploma in Clinical Research (PDCR) October 2012
Catalyst Clinical Services Pvt. Ltd., Delhi
Introduction to Pharmaceutical Medicine, Good Clinical Practice (GCP) Foundations, Drug Regulatory Affairs (Clinical Trials), Roles and Responsibilities of Clinical Trial Personnel

II] Bachelor of Homoeopathic Medicine & Surgery (BHMS) July 2010
Bharati Vidyapeeth Deemed University, Pune
In-depth knowledge of medicines and surgery with 1-year Internship at multiple homeopathic centers.