• Conduct outreach to patients to gauge interest in ophthalmology clinical research studies, effectively communicating study protocols and associated risks to ensure informed decision-making.• Guide patients through the informed consent process, ensuring they comprehend all study aspects before enrollment to promote transparency and understanding.• Coordinate patient clinic visits, managing scheduling and reimbursement processes to enhance the participant experience and ensure smooth logistics.• Collaborate with clinical teams to uphold adherence to study protocols and regulatory requirements throughout the research process, ensuring high standards of compliance.• Develop and implement communication strategies to keep patients informed about study progress and any protocol changes• Conduct follow-up calls with participants to monitor their progress and address any questions or concerns, ensuring continued support throughout the study.• Assist in the collection and management of study data, ensuring timely and accurate data entry that meets regulatory standards and supports research integrity.• Participate in training sessions and meetings to stay updated on advancements in ophthalmology research and regulatory changes• Collaborate with the Principal Investigator and study sponsors to facilitate efficient study implementation and compliance with Good Clinical Practice (GCP) guidelines.• Prepare and maintain documentation for audits and monitoring visits, ensuring all regulatory requirements are met and facilitating smooth inspections.• Assist in developing study materials, including informational brochures and consent forms, to enhance patient understanding and improve enrollment processes.• Monitor study budgets and expenditures related to patient reimbursement, ensuring compliance with financial policies and effective resource management.

• Facilitate patient qualification discussions with the Principal Investigator to ensure alignment with study protocols.• Utilize Electronic Medical Records (EMR) for screening and identifying eligible patients, enhancing recruitment efficiency.• Report Adverse and Serious Adverse Events to the Institutional Review Board (IRB) and Sponsor, ensuring compliance with regulatory guidelines and maintaining patient safety.• Obtain and document informed consent following ICH guidelines and Good Clinical Practice (GCP) to ensure ethical compliance.• Ensure timely and accurate data entry per the ALCOA principle, maintaining high data quality standards.• Organize and collect source data in the electronic source system, ensuring integrity and accessibility for monitoring and audits.• Resolve outstanding items from previous monitoring visits, proactively addressing compliance issues to enhance study quality.• Address and close queries from prior visits, facilitating effective communication between study teams and regulatory bodies.• Maintain temperature and accountability logs to ensure compliance with storage requirements for investigational products.• Plan subject visits according to protocol-specific schedules, optimizing patient engagement and study timelines.• Prevent protocol deviations by closely monitoring procedures and implementing corrective actions as needed.• Coordinate with site administration to ensure availability of space and resources for study activities.• Dispense and collect study medication, maintaining accurate Investigational Product accountability.• Collect and process laboratory specimens according to study protocols for timely data collection.• Complete Case Report Forms (CRFs) and patient tracking documentation accurately and promptly to support efficient data management.• Maintain comprehensive knowledge of data collection instruments, ensuring adherence to protocols and enhancing data accuracy.

• Assembled and maintained regulatory documents in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional SOPs for oncology clinical trial operations, ensuring seamless activation and amendments.• Maintained a regulatory document control system, enhancing organizational efficiency and compliance tracking.• Coordinated with multidisciplinary research teams to execute oncology clinical trials, overseeing patient enrollment, site initiation visits (SIV), and adherence to protocol timelines.• Communicated effectively with internal reviewers and external agencies, providing clear updates and addressing regulatory queries related to clinical trials.• Collaborated with physicians, research nurses, and data managers to ensure accurate documentation of patient care and strict compliance with study protocols.• Prepared documentation for IRB submissions and patient enrollment, including study protocols, informed consent forms, and confidentiality agreements, ensuring thorough regulatory compliance.• Guided participants through the informed consent process, fostering transparency and understanding while maintaining Investigator Site Files and Trial Master Files.• Participated in routine monitoring visits, providing timely responses to sponsor and auditor regulatory queries• Tracked changes in regulatory laws and guidelines, communicating updates to team members and assisting in the coordination and implementation of process improvements.• Performed clinical monitoring tasks for trials, including site qualification, initiation, routine monitoring, and close-out, ensuring adherence to protocol and regulatory requirements.• Submitted required clinical trial regulatory documents in a timely manner, including IND-related documents for the Compliance Office and oversight of the FDA approval process.• Communicated with sponsors regarding clinical trial regulatory document submissions, and ensured alignment with regulatory expectations.

• Assisted with quality assurance reviews of protocol related data as well as protocol specific regulatory documents• Conducted study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.• Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.• Completed data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.• Performed all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards maintained and ensured all documentation is in a state of audit-readiness• Ensured strong attention to detail when maintaining accurate and organized research records including CAPAs and case report forms• Maintained a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).• Employed good clinical documentation practices when collecting and correcting data and transcribed clinical site queries for subsequent quality assurance review• Attended all project meetings to actively participate in the planning, audit, and management of new & ongoing studies.•Tracked Quality assurance reports and returns and followed up with all delinquent sites • Assisted in preparation of site for scheduled external audits, to include pre-audit activities to ensure readiness

• Facilitated patient enrollment processes by accurately gathering and verifying medical records, ensuring compliance with organizational and regulatory guidelines.• Streamlined data entry and management of patient information into electronic medical record systems (EMRs), maintaining a high level of accuracy and confidentiality.• Collaborated with healthcare teams to input and update critical patient data, ensuring real-time accessibility for informed decision-making.• Monitored and validated data accuracy to identify and address discrepancies, contributing to effective patient care coordination.• Supported clinical staff by providing timely and organized patient information, enhancing workflow efficiency and care delivery.• Maintained compliance with HIPAA regulations and organizational protocols for handling sensitive patient information.• Generated detailed reports to assist in clinical planning and quality improvement initiatives.• Utilized advanced EMR systems to enhance data tracking and documentation, ensuring seamless integration with ongoing care strategies.