Clinical Research Coordinator - Neurology and Cardiology

Fort Worth, USA • ***************@*****.*** • 214-***-****

DIVYA VASIMALLA

Clinical Research Coordinator

PROFESSIONAL SUMMARY

Clinical Research Coordinator with experience supporting observational and interventional neurology, alzheimer's and cardiology studies simultaneously. Proficient in participant screening and enrollment, informed consent, cognitive assessments

(MMSE, MoCA, CDR), accurate EDC data entry, regulatory binder maintenance, and audit support to ensure ICH-GCP, FDA, HIPAA, and IRB compliance. Skilled collaborator with investigators, sponsors, and vendors, focused on protocol adherence, improving patient care and data quality, and expanding responsibilities in protocol development and study coordination to drive efficient, patient-centered trial delivery. EMPLOYMENT HISTORY

CLINICAL RESEARCH COORDINATOR Dec 2024 - Feb 2026

Gadolin Research Beaumont

PHARMACY TECHNICIAN Mar 2023 - Nov 2024

Kroger Pharmacy Texas

Engage in clinical trial management on a day to day level. Work closely with the project CTM for timely delivery of recurrent tasks consistently with a high degree of accuracy. Compile and maintain project-specific status reports. Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies. Able to work independently as well as in a team. Professional attitude with good customer focus (internal and external). Time Management as safety notifications, eTMF etc. need to be done in a timely manner. Provide oversight and quality control of our internal regulatory filing system. Maintained subject confidentiality and ensured regulatory compliance with FDA, GCP, ICH, HIPAA, and IRB standards. Conducted informed consent, medical history, adverse event capture, vitals, and treatment coordination for study subjects. Prepared study documentation and coordinated new site setup to enable prompt trial initiation. Acted as liaison with sponsors and vendors to streamline study communications and operations. Coordinated monitor visits and audit inspections to maintain inspection readiness. Responded promptly to internal and external information requests to support study timelines. Screened and recruited subjects to meet enrollment targets and support study progress. Maintain up to date participating center's information (including all contact details). Responsible for preparing the Investigator and Sponsor files (electronic and/or paper) with essential documents for the initiation of sites participating in clinical studies. Assist client study staff with maintaining the sponsor files during the life of the study. Provide administrative support/accelerate the preparation, collation, review, tracking and filing of all documentation required for regulatory and/or ethics committee submissions. Identified opportunities to improve patient care and satisfaction during study visits. Conducted patient-facing encounters with empathy to support retention and participant experience. Reviewed medical records against inclusion/exclusion criteria to identify eligible subjects. Verified subject eligibility prior to dosing and monitored subjects post-dose for safety. Documented adverse events accurately on required forms to support safety reporting. Transcribed source documents to the EDC promptly and per protocol to maintain data integrity. Answered EDC queries within required timeframes and resolved study queries to preserve data quality. Attended investigator meetings, pre-study visits, initiation visits, and sponsor-hosted study visits as required. Processed and verified prescriptions accurately to ensure timely medication delivery and maintain compliant patient records. Assisted pharmacists with medication preparation and insurance claim resolution, reducing prescription delays and improving patient satisfaction.

Managed cold-chain procedures and monitored storage conditions to preserve medication integrity and support reliable treatment outcomes.

Implemented shelf organization by medication class to accelerate retrieval, yielding noticeable reductions in prescription preparation time and customer wait.

CLINICAL RESEARCH COORDINATOR Nov 2021 - Sep 2022

Jeevan Scientific Technology Limited Hyderabad

CLINICAL PHARMACIST INTERN Mar 2021 - Oct 2021

Lalitha Super Speciality Hospital

EDUCATION

DOCTOR OF PHARMACY 2015 - 2021

Acharya Nagarjuna University India

Designed a checklist-driven workflow for high-volume shifts to prioritize tasks and minimize errors, delivering steadier throughput during peak periods.

Optimized OTC restock routines and shelving sequence to shorten customer wait at pickup and support faster prescription handoffs during peak hours.

Managed insurance documentation checks and streamlined submission steps for complex claims, reducing back-and-forth and facilitating timelier patient access to medications. Provide inputs on protocol preparation from clinical perspective, based on therapeutic area & study phase. Responsible for Sponsor facing clinician role, for all clinical decisions, during pre-study, study execution, post study activities till clinical study report.

Provide protocol and therapeutic area training to study teams (both internal and external). Provide response to study investigator/Ethics committee queries. Prepare study specific medical monitoring plan.

Review of Protocol deviations, on real time basis. Review of Clinical study report / Site Monitoring Plan etc. Review study subject reports (like Medical history, lab reports, ECG report, cytology, 2D-ECHO, CT, Bone Scan reports, any clinical assessments etc, as applicable) for eligibility in coordination with Project Manager/Designee. SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly. Develop & Review protocol amendments (if required) and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan.

Responsible for review of Adverse event and Serious adverse event data in the clinical trial for its completeness and accuracy. Validate follow-up request and perform medical assessment of the case for the Category I and II cases. Prioritize workloads to ensure expedited cases are processed within defined timelines. Conducted comprehensive patient evaluations, documented medical histories, and prescribed treatments to support measurable clinical outcomes.

Managed and interpreted ultrasound, ECG, and echocardiogram results to improve diagnostic accuracy and inform treatment decisions.

Coordinated medication therapy across General Medicine, Orthopedics, Neurology, Cardiology, OB&GYN, and Psychiatry to support interdisciplinary care and adherence.

Dispensed medications and counseled patients while collaborating with physicians to optimize pharmacotherapy and patient outcomes.

Provided targeted patient counselling on medication use and side-effect management, increasing adherence and enhancing patient confidence in therapy.

Facilitated multidisciplinary rounds to resolve complex drug-related problems, strengthening clinician communication and expediting treatment decisions.

Strong academic training in pharmacology, clinical therapeutics, drug safety, and evidence-based medicine relevant to clinical research.

Coursework included Clinical Research, Pharmacovigilance, Biostatistics, and Ethics in Clinical Trials. I have good clinical and Research knowledge.

Strong attention to detail and documentation accuracy. Ability to follow protocols and standard operating procedures. Comfortable interacting with patients and healthcare teams. Quick learner with strong interest in clinical research operations. Clinical Rotations: Engage in experiential learning, with the fourth year primarily focused on rotations in various settings, including community, hospital, and ambulatory care. Patient Care Activities: Engage in rotations work with health teams to review patient charts, check medication dosages, analyze lab values, and provide counseling.

Active Learning: Curriculum involves team-based learning, case studies, and simulation labs to apply knowledge of medicinal chemistry and pathophysiology.

Research & Projects: clinical research, drug studies, or topic discussions. SKILLS

Adverse events, Data Analysis, Clinical Trials, Risk Assessment, Project Management, Team work, Problem Solving, Data Collection, ICH GCP guidelines, Regulatory Affairs, Study Design. ADDITIONAL INFORMATION

RESEARCH PROJECTS

PUBLICATION

My paper Publication to WJPPS (World Journal Pharmacy And Pharmaceutical Science) Title: A Review article on dietary modification in treatment of PCOS.

Intern Positions: Worked as licensed pharmacy interns, performing duties such as dispensing, vaccinations, and medication safety checks.

Research project published about Efficacy of the combination of tadalafil and tamsulosin versus tadalafil alone as a medical expulsive therapy for stone 7 mm or less: A prospective comparative placebo-controlled study. Conducted literature review and data analysis as part of a PharmD research project. Applied principles of clinical research methodology and ethics. Presented research findings in written and oral formats.

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