MAULIKA DHADA
New Jersey,NJ
Summary
Clinical research professional with solid experience in managing and monitoring clinical trials. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in data analysis, protocol adherence, regulatory compliance, and patient interaction. Reliable and prepared to make impactful contribution to clinical research initiatives.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate-II
Cliantha Research Limited
08.2023 - 10.2023
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study.
Clinical Research Associate
Lambda Therapeutic Research Pvt. Ltd
04.2021 - 08.2023
- Conducted site evaluations to ensure compliance with study protocols and regulatory requirements.
- Assisted in the preparation and submission of clinical trial documentation to regulatory bodies.
- Recruit and enroll study participants.
- Input clinical research data into electronic data systems.
- Coordinate patient visits and procedures related to research.
- Act as resource for study participants by answering questions and explaining related procedures.
- Ensure the study site is compliance with all local and federal laws and regulations.
- Monitor study sites and activities to ensure the the appropriate industry protocols and terms of the study are being followed.
- Oversee the hiring and training of staff members who are working on the study.
- Create thorough documentation of study protocol and update it as needed.
- Directing the 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.
Clinical Trial Assistant
Lambda Therapeutic Research Pvt. Ltd.
11.2018 - 03.2021
- Coordinated regulatory submissions and documentation to ensure compliance with trial protocols.
- Managed scheduling of study visits and maintained communication with clinical sites.
- Answered telephone calls to offer office information, answer questions, and direct calls to staff.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Obtained and documented patient medical history, vital signs and current complaints at intake.
- Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
- Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
- Support the Clinical Operations teams with ongoing conduct of studies.
- Ensure compliance with Good Clinical Practice (GCP), appropriate regulations, relevant Standard Operating Procedures (SOPs), and internal tracking systems.
- Assist project teams with study-specific documentation and guidelines.
- Set up, organize, and maintain clinical study documentation, including preparation for internal/external audits, final reconciliation, and archival.
- Process Data Collection Forms, log in, track, and perform quality control as appropriate for the study.
- Perform quality control audits of clinical study documentation.
- Co-ordinate ordering/dispatch and tracking of trial materials, such as CRFs, diary cards, lab supplies, and drug supplies, as appropriate.
- Assist project teams with trial progress tracking by updating the Clinical Trial Management System (CTMS).
- Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
- Assist in co-ordination of Investigator payments,
Study Coordinator
Shree Krishna Hospital And Heart Care Center
05.2016 - 11.2018
- Coordinated study schedules, ensuring compliance with protocols and timelines.
- Managed participant recruitment, screening, and enrollment processes effectively.
- Facilitated communication between research teams and external stakeholders to enhance collaboration.
- Developed training materials and conducted sessions for new staff on study procedures.
- Assisted in preparing regulatory documentation, maintaining adherence to ethical standards.
- Facilitated timely enrollment of participants through targeted recruitment strategies.
Education
Master of Science - Information Technology
University of North America Main Campus
Virginia09-2025
Master of Science - Clinical Research
Gujarat University
Ahmedabad-India05-2017
Bachelor of Science - Chemistry
M.G. Science Institute
Ahmedabad-India04-2014
Skills
- Research SOPs understanding
- Medication dispensing
- Good Clinical Practices
- Trial management
- Study protocols clear understanding
- Schedule Coordination
- Interpersonal Communication
- Excellent Communication
- Self-Motivated
- Critical Thinking
- Multitasking Abilities
- Attention to Detail
- Active Listening
Timeline
Clinical Research Associate-II
Cliantha Research Limited
08.2023 - 10.2023
Clinical Research Associate
Lambda Therapeutic Research Pvt. Ltd
04.2021 - 08.2023
Clinical Trial Assistant
Lambda Therapeutic Research Pvt. Ltd.
11.2018 - 03.2021
Study Coordinator
Shree Krishna Hospital And Heart Care Center
05.2016 - 11.2018
Master of Science - Information Technology
University of North America Main Campus
Master of Science - Clinical Research
Gujarat University
Bachelor of Science - Chemistry
M.G. Science Institute
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