Hetaben Desai

Study - COPD

• Protocol Compliance: Maintained compliance with protocols covering patient care and clinical trial operations per ICH/GCP standards and FDA regulations.
• Eligibility Assessment: Assessed patient's eligibility criteria following strict adherence to inclusion/exclusion guidelines.
• Consent Preparation: Prepared detailed informed consent documents to communicate risks, benefits, expectations, rights, and responsibilities related to participation in clinical trials.
• Candidate Screening: Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Trial Coordination: Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Follow-Up: Increased participant retention rates through proactive follow-up efforts and regular engagement activities.

• Documented Patient Interactions: Accurately recorded patient histories, examination findings, and treatment plans, ensuring comprehensive and detailed medical records.
• Enhanced Research Efficiency: Provided detailed documentation (HPI and ROS) and accurate data entry that supported research initiatives and clinical trials, contributing to the analysis and reporting of study results.
• Maintained Confidentiality: Ensured compliance with HIPAA regulations and maintained strict confidentiality of patient information.
• Facilitated Communication: Acted as a liaison between patients and medical staff, enhancing communication and ensuring patient concerns were accurately documented and addressed.
• Supported Clinical Workflow: Collaborated with the physician and healthcare staff to streamline patient care processes and maintain protocol adherence.

Study - Diabetic Macular Edema

• Protocol Adherence: Ensured compliance with clinical trial protocols and regulatory requirements according to GCP and ICH relevant SOP's.
• Data Collection & Management: Collected, recorded, and managed trial data, ensuring accuracy and completeness in line with study protocols.
• Documentation: Preparing central investigator files (CIF), trial master files (TMF) and electronic trial master files ( eTMF ) for the initiation of participating centers in clinical studies.
• Monitoring & Reporting: Conducted site visits and monitoring to ensure protocol compliance, and generated progress reports for sponsors and stakeholders.
• Adverse Event Tracking: Maintained CTMS for assigned projects, tracked all information and production of status reports for project team and sponsors, as needed following regulatory requirements and study protocols.
• Data Analysis: Assisted in analyzing trial data and preparing reports for interim and final study result.