I Medidata
Pratik R. Lokhande
Medical Research Associate (Clinical Research Coordinator)
Mumbai,Maharashtra
Summary
Knowledgeable Medical Research Associate adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues.
Overview
3
3
Language
2
2
Certifications
3
3
years of professional experience
Work History
Clinical Research Coordinator (Research Associate)
Kokilaben Dhirubhai Ambani Hospital
02.2023 - Current
- Managed all aspects of study execution, from site initiation visits (SIVs), site monitoring visits, and close-out activities, serving as the primary point of contact for sponsors, principal investigators, and the finance team.
- Facilitated the informed consent process under the guidance of the PI, ensuring participants understood the study procedures, risks, and benefits.
- Investigator Site File Maintaining (TMF) Management: Oversaw data collection, entry, and quality control using EDC and CTMS systems, resolving data queries promptly, and ensuring data integrity. (e.g., i-Medidata).
- Prepared and submitted regulatory documents, including consent forms, and protocol amendments to the Ethics Committee and sponsor.
- Monitored participant safety and well-being, conducted study visits, performed basic clinical procedures (specimen collection, centrifugation), and documented adverse events per protocol.
- Oncology Experience: ICMR - Prospective Study (POCSS and HBCR).
- Review the microscopic description, specimen type, laterality, topography, morphology, malignancy, TNM staging, and grading from the electronic health record. Also, review the types of treatment, such as surgery, chemotherapy, radiation therapy, and hormone therapy details, and enter them in the assigned portal.
- Extract and manage data from reports as per protocol.
Maintain participants' strict confidentiality. Identify, track, and correct data discrepancies to maintain the integrity of research data. - Review histopathology reports, and record surgery details and staging details. Figo, TNM, and an Arber Staging.
- Managed participant recruitment strategies to optimize enrollment rates for multiple studies.
Clinical Research Coordinator (Trainee)
LifePoint Institute
12.2021 - 05.2022
- Supported pediatric vaccine and psychiatric trials (bipolar disorder).
- Conducted subject screening and managed source documentation and data collection to support trial integrity.
- Coordinated informed consent process and maintained site documentation to ensure regulatory compliance.
- Entered E-CRF data while resolving queries during monitoring visits to enhance data accuracy.
Education
PGDM - Clinical Research
LifePoint Institute
Pune01-2022
Bachelor of Pharmacy - Pharmacy
ACP Chikhli
Chikhli, India 04.2001 -
High School Diploma -
Shri Santaji Jr College
Aurangabad, India 04.2001 -
No Degree - Science
Shri Shivaji High School
Chikhli, India 04.2001 -
Skills
Clinical trial management
Regulatory submissions
Good clinical practices
EDC systems
Documentation management
Adverse event reporting
Adverse event tracking
Study protocols
Informed consent
Patient recruitment
Sample processing techniques
Product management
Software
Labcorp
Signet
Clario
Judi
Certification
Advanced PGDM in Clinical Research, Pharmacovigilance, CDM – Lifepoint Institute, Pune
Timeline
Clinical Research Coordinator (Research Associate)
Kokilaben Dhirubhai Ambani Hospital
02.2023 - Current
Clinical Research Coordinator (Trainee)
LifePoint Institute
12.2021 - 05.2022
Bachelor of Pharmacy - Pharmacy
ACP Chikhli
04.2001 -
High School Diploma -
Shri Santaji Jr College
04.2001 -
No Degree - Science
Shri Shivaji High School
04.2001 -
PGDM - Clinical Research
LifePoint Institute
Declaration
I hereby declare that the above information is true to the best of my knowledge and belief. Pratik Lokhande Mumbai
Conferences & Workshops
- Investigator's Meeting – Hyderabad (Jan 2025)
- ICH-GCP E6 (R3) Workshop – KDAH, Mumbai (Feb 2025)
- ET Pharma Conference – Mumbai (Apr 2025)