KIMAYA MOHITE
Katy,TX
Summary
Dedicated clinical operations professional with expertise in supporting clinical trials through meticulous documentation and organisation of trial master files. Proficient in ETMF filing, quality control, and regulatory document management, ensuring adherence to ICH GCP guidelines and FDA regulations. Skilled in protocol support, informed consent form management, and study communications, enhancing the efficiency of clinical tracking systems and status reporting. Adept at monitoring visit report tracking and case report form data review, leveraging Microsoft Word, Excel, and PowerPoint for effective SOP adherence. Committed to advancing clinical research processes with a focus on precision and compliance.
Overview
3
3
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work history
Student Observer
Texas Arthritis and Rheumatology Associates
Katy
2025.12 - 2025.12
- Observed outpatient management of autoimmune diseases including rheumatoid arthritis and Raynaud’s syndrome
Research Intern Nutrition and Behavioral Health Project
Touro University California
2025.08 - 2025.12
- Created research design literature review plus data analysis for over 100 human subjects behavioral health and nutrition research
- Supported survey development participant data intake integrity checks and regulatory compliant documentation
- Applied study protocols and maintained accurate research records to support compliance and data quality
- Organized and maintained essential study documents including regulatory files training records and study communications to support Clinical Operations
Cancer Immunotherapy Manuscript Contributing Author
Liu Lab University of Houston
2025.05 - 2025.12
- Conducted literature reviews on antibody drug conjugates immunotherapies and macromolecular therapeutics to support manuscript development
- Extracted and synthesized peer reviewed clinical and preclinical data to support accurate reporting of therapeutic mechanisms and outcomes
- Evaluated study methodology sample sizes and outcome measures across oncology publications to support evidence based conclusions
Medical Scribe
IKS Health and Acuity Solutions Cleveland Clinic
2024.08 - 2025.09
- Documented over 100 physician patient encounters in Epic EMR across outpatient clinical settings
- Ensured accurate timely and HIPAA compliant clinical documentation aligned with SOAP note standards
- Reviewed clinical records for completeness accuracy and consistency to support compliance requirements
- Supported accurate clinical documentation and data entry within electronic systems aligned with regulatory and SOP requirements
Cardiac Medical Intern
D.Y. Patil University & Hospital
Mumbai, India
2023.12 - 2024.01
- Developed strong interpersonal skills through daily interactions with 50+ diverse patients under Dr. James Thomas
- Delivered high-quality patient care by working collaboratively with multidisciplinary teams.
- Consulted with patients, ensuring comfort during hospital stay.
- Performed various administrative tasks efficiently, reducing workload for senior staff members.
Cardiovascular Systems Researcher
Aggie Research Program Texas A&M University
2023.08 - 2023.12
- Conducted research using systems based physiological modeling to simulate cardiovascular function
- Documented research methods model outputs and findings in structured reports for formal submission
- Followed defined research methodologies and maintained organized records to ensure data accuracy and reproducibility
Shadow
Cinco Ranch Dermatology Clinic
Katy, Texas
2023.05 - 2023.08
- Gained exposure to longitudinal patient care as well as biologic therapies and highly complex surgical interventions
- Analyzed 50+ dermatologic evaluations including biopsy procedures and patient-centered educational practices
Global Outreach Intern
Akklakot Outpatient Clinic India
2022.12 - 2023.01
- Supported clinical operations and medical documentation in a rural outpatient clinic serving underserved populations
- Observed care delivery in a resource limited setting with constrained sterilization and limited medical supplies
Education
Master of Science - Medical Health Sciences
Touro University California
Vallejo, California 2025.08 - 2026.01
Bachelor of Science - Biomedical Sciences, Minor Business
Texas A&M University
2021.08 - 2025.05
Skills
- Clinical Operations support
- Clinical trial documentation
- Trial master file organization
- ETMF filing and quality control
- Regulatory documents and study binders
- Protocol and Informed Consent Form support
- Study communications and training records
- Clinical tracking systems and status reporting
- Monitoring visit report tracking
- Case report form and data review support
- ICH GCP guidelines and FDA regulations
- SOP adherence
- Microsoft Word Excel PowerPoint
Certification
- HIPAA Compliance Training
- CPR and BLS Certification
- Biomedical Research Certificate
- Dean’s List Texas A&M University
REGULATORY KNOWLEDGE
Working knowledge of ICH GCP guidelines FDA clinical research requirements and SOP driven clinical trial processes
Timeline
Student Observer
Texas Arthritis and Rheumatology Associates
2025.12 - 2025.12
Master of Science - Medical Health Sciences
Touro University California
2025.08 - 2026.01
Research Intern Nutrition and Behavioral Health Project
Touro University California
2025.08 - 2025.12
Cancer Immunotherapy Manuscript Contributing Author
Liu Lab University of Houston
2025.05 - 2025.12
Medical Scribe
IKS Health and Acuity Solutions Cleveland Clinic
2024.08 - 2025.09
Cardiac Medical Intern
D.Y. Patil University & Hospital
2023.12 - 2024.01
Cardiovascular Systems Researcher
Aggie Research Program Texas A&M University
2023.08 - 2023.12
Shadow
Cinco Ranch Dermatology Clinic
2023.05 - 2023.08
Global Outreach Intern
Akklakot Outpatient Clinic India
2022.12 - 2023.01
Bachelor of Science - Biomedical Sciences, Minor Business
Texas A&M University
2021.08 - 2025.05