Clinical Research Coordinator

Gayathri Devi Amboru

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Summary:

• A highly motivated and detail-oriented Clinical Research Coordinator with hands-on experience in managing and coordinating clinical trial. Demonstrates proficiency in ensuring compliance with reg- ulatory requirements, maintaining accurate documentation, and managing participant recruitment and retention. Skilled in working with multidisciplinary teams to facilitate the execution of clinical studies, from protocol development to final reporting.

• Strong organizational and communication skills, adept at monitoring trial progress, maintaining safety protocols, and ensuring high data quality standards.

• Experienced with electronic data capture systems and managing patient consent processes. Professional Experience:

Clinical Specialist: Visionworks of America/ Rockway, NJ Oct 2024- present

• Assist the doctor with patient care and eye examinations.

• Clearly explain the preliminary testing process to patients, administer each test, and accurately doc- ument the results in EMR.

• After the exam, transition the patient to a retail associate, conveying the doctor's recommendations to the associate.

• Schedule appointments and manage exam books according to Company guidelines, call appoint- ments in accordance with company policy to confirm time. Contact no-shows and cancellations, and complete nightly patient readiness tasks.

• Have a basic understanding of MVC plans and be able to articulate plan benefits to patients.

• Preauthorize insurance by standard operating procedures.

• Maintain patient flow to allow for doctor effectiveness.

• Answer patients’ clinical questions in person and over the telephone. Triage ocular emergencies. Schedule annual eye exams.

• Maintain complete and accurate patient records according to Company standards.

• Instruct patients on the insertion, removal, cleaning, care, and proper handling of their contact lenses.

Clinical research coordinator Clinztech research solutions/ Hyderabad, India Aug2020- Feb 2022 Responsibilities as a Clinical Research Coordinator at ClinzTech Research Solutions: o Assist with the preparation and execution of clinical research studies, ensuring adherence to protocols and timelines.

o Coordinate all aspects of the trial, from study initiation through close-out, ensuring that the project remains on track.

o Monitor the study's progress, making necessary adjustments to ensure compliance and mini- mize delays.

o Ensure all clinical trials are compliant with relevant regulatory bodies (e.g., IRB, FDA, GCP guidelines).

o Maintain and manage essential regulatory documents such as consent forms, case report forms, and protocol amendments.

o Prepare and submit documentation for Institutional Review Board (IRB) and other regulatory agencies as requirements

o Assist in the recruitment and screening of study participants, ensuring they meet the inclu- sion/exclusion criteria.

o Ensure informed consent is obtained and that participants understand the study’s scope, po- tential risks, and benefits.

o Maintain accurate records of enrollment, informed consent, and participant demographics in EPIC software-based EHR.

o Collect, process, and manage study data, ensuring it is accurate, complete, and compliant with applicable regulations.

o Electronic data capture (EDC) systems are used to input and monitor study data. o Ensure all data entries are accurate and completed promptly, troubleshooting discrepancies when necessary.

o Monitor participants throughout the trial, assessing for adverse events and ensuring that ap- propriate action is taken.

o Maintain participant safety by adhering to safety monitoring guidelines, reporting adverse events on time.

o Ensure follow-up visits are scheduled and conducted according to the protocol, documenting any changes in participant status.

o Maintain accurate and up-to-date study documentation, including progress reports, case re- ports, and adverse event reports.

o Generate study progress reports for internal and external stakeholders. o Assist in the preparation of study summaries and final reports for sponsors and regulatory bodies.

o Serve as the point of contact between clinical research staff, Principal Investigators (PIs), study sponsors, and other stakeholders.

o Attend and participate in team meetings to review study progress, discuss issues, and imple- ment solutions.

o Communicate any protocol deviations or issues to the appropriate parties and work to resolve them efficiently.

o Conduct routine site visits and audits to ensure that the trial is being conducted according to the protocol and regulatory standards.

o Assist with quality control measures and ensure all trial documentation is organized and au- dit-ready

o Support the training of new staff, including research assistants or other CRCs, on study proce- dures, GCP, and company protocols.

o Stay updated on industry trends, best practices, and regulatory changes to ensure compliance. ACCADEMIC SKILLS: IND,NDA,510K, ICH GUIDELINES, CAPA, WARNING LETTERS, DRUG RECALLS, 21 CFR 11, 50,54,201,56,201.66,300,600,800.

Pharamaceutical instruments handling: Dissolution apparatus, disintegration apparatus, Tablet and cap- sules quality control tests, microbiological testing, autoclave, working in clean room equipment, culturing the mediums, sterilizing techniques, Ph meter.

HPLC, UV instrumentation calibration and analysing the compounds under the guidance of professor. Working under the lab environment following all the GMP and GLP guidelines. EDUCATION:

• Master in Regulatory Affairs, Northeastern University, Massachusetts, Boston, USA.

• Bachelor's in pharmacy, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India. Projects:

Enhancement of bioavailability of Ritnovir drug through solid dispersion technique. eCTD submission of predictive device in ELI health medical device based compatibility. Certifications:

Adult first aid/CPR/AED by AMERICAN RED CROSS.

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