PROFESSIONAL EXPERIENCE

Senior Clinical Research Coordinator and Manager
Dr. Rajesh Swarnakar (Director & Chief Pulmonologist)                        
Getwell Hospital and Research Institute, Nagpur                            Jul 2024 – Present

Clinical Research Coordinator
Anil Sontakke Professor & HOD (MD TB & Chest)
Lata Mangeshkar Hospital, Nagpur                                                 Jan 2024 – Jul 2024

Clinical Document Specialist-II (e-TMF)
TransPerfect Life Sciences, Pune (Remote)                                               Jan 2023 – Jan 2024

Clinical Research Coordinator
Ardent Clinical Research Services,
Lata Mangeshkar Hospital, Nagpur                                                           Jul 2019- Jan 2023

Clinical Research Coordinator
S4 Research, Lata Mangeshkar Hospital, Nagpur                                    Sep 2018 – Jul 2019

Clinical Research Coordinator
Dr. Anand Pathak,
Meditrina Institute of Medical Sciences, Nagpur                                       Aug 2017 – Sep 2018

Clinical Research Coordinator
Dr. Sunil Ambulkar, Institute of Clinical Endocrinology
And Diabetes Care Unit), Nagpur                                                               Jul 2010 – Jul 2011

Total 7 year experience of Clinical Research 

Study Management:
Oversee the day-to-day operations of clinical trials, ensuring adherence to study protocols and regulatory guidelines.
Coordinate study initiation, execution, and closeout activities.

Participant Recruitment and Consent:
Identify, recruit, and screen eligible study participants.
Obtain and document informed consent from participants in compliance with ethical standards.

Data Collection and Documentation:
Collect, record, and maintain accurate clinical data.
Enter data into electronic data capture systems (EDCs) and ensure data quality and integrity.

Regulatory Compliance:
Prepare and submit regulatory documents to IRBs/ethics committees.
Ensure compliance with ICH-GCP guidelines, FDA regulations, and local regulatory requirements.

Monitoring and Reporting:
Conduct regular monitoring visits and audits to ensure study compliance.
Report adverse events and deviations promptly to investigators and sponsors.

Patient Care and Safety:
Monitor participants for adverse events and provide necessary care and support.
Ensure proper follow-up and documentation of participant health and safety.

Communication and Coordination:
Serve as a primary liaison between investigators, participants, sponsors, and regulatory authorities.
Facilitate effective communication and coordination among the research team.

Training and Mentorship:
Train and mentor junior staff and new team members on study protocols and procedures.
Stay updated with industry trends and regulatory changes.

Quality Assurance:
Implement quality control measures to ensure data accuracy and study integrity.
Conduct internal audits and address any discrepancies or issues.

Budget and Resource Management:
Assist in budget preparation and manage study-related expenses.
Ensure efficient use of resources and adherence to financial constraints

EDUCATION & CERTIFICATIONS

Master of Science (M.Sc) Medical Biotechnology – (2009)

Pravara Institute of Medical Sciences, Ahmendnagar

Post Graduate Program in Clinical Research and Data Management – (2010)

Eduedge Academy, Nagpur

Industry Program in Pharma Quality Assurance and Quality Control – (2015-16)

Bioinformatics Institute of India, Noida