Data Entry Clinical Research

Karumoori Tejaswi

Chicago, IL

Summary

A dedicated Clinical Researcher with a strong foundation in disease progression, the drug development process, and their critical impacts on patient outcomes.

Skilled in clinical research data entry and experienced in planning, directing, and coordinating project activities to meet timelines effectively.

Proficient in utilizing various EDC systems, Medidata Rave, conducting Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), with expertise in Site Management and Regulatory functions.

Demonstrates strong administrative capabilities in supporting clinical studies conducted in the field, with efficient handling of regulatory documentation, protocol processing, and amendments.

Known for effective multitasking, prioritization, and excellent decision-making abilities, even under minimal supervision.

Utilized MS Excel to track essential documents, patient enrollment, and clinical trial metrics

Possesses superb interpersonal, verbal, listening, and writing skills, alongside a talent for problem-solving, analysis, and negotiation to achieve team and individual objectives.

Committed to continuous learning and personal growth, bringing a strong work ethic and adaptability to new environments.

Proven track record of patient recruitment, conducting visits from screening through randomization independently, and maintaining Source Documents with precision, avoiding protocol deviations.

Education

Masters, Health Administration, Indiana Wesleyan University, Florence, Kentucky, August 2024)

Professional Experience

Jersey Shore University Medical Center, Neptune, NJ 03/23 – 09/24

Volunteer Clinical Research Assistant

Develop, send, collect, review, and process clinical trial-related documents (i.e., informed consent forms, FDA forms, curriculum vitae, financial disclosure forms, etc.) in compliance with requirements set forth by regulatory agencies (e.g., FDA, EMEA, ICH-GCP, SOPs, and working practice guidelines, etc.)

Maintain tracking tools and spreadsheets of required investigative site essential documents and contact information.

Assist with the preparation of study amendments, laboratory manuals, and other clinical trial-related documents as assigned.

Maintain and coordinate the generation of clinical trial status reports and tracking spreadsheets and/or databases.

Utilize MS Excel to track essential documents, patient enrollment, and clinical trial metrics

Generated and reviewed management reports from internal tracking systems at requested intervals.

Participate in cross-functional internal study team meetings and take minutes as requested.

Will take direction and instruction from the Lead Clinical Trial Specialist.

Carrying out periodic Inspection and Audit as per SOPs.

Conducting the audit of Vendor/Third-party service providers.

Collect and track patient enrollment information and update study management reports as necessary.

Archiving the study reports and related documents.

Freelance Medical Writer, Chicago, IL 12/17 – 02/22

Managed projects including e-CRF writing, protocol reviewing, manuscript development, blog posts, patient education material, newsletters, and medical website content.

Gained a real-life experience of residency training, and attended residents’ morning reports, noon lectures, and grand rounds.

Followed patients with the Obstetrics and Gynecology team, Psychiatry team, and Emergency medicine.

Gained hands-on experience in a busy Family medicine clinic, under the direct supervision of a family physician.

Obtained history, performed physical exam, and presented cases to the attending physician with provisional diagnosis and management plan.

Maintained electronic medical records of patients whom I attended.

Educated patients on health issues when necessary.

Won the trust of the attending physician by timely and efficient work.

Gained hands-on clinical experience in the Intensive Care Unit, Internal Medicine, and Pediatric Units.

Worked closely with residents and medical students and did case presentations to the attending physician during ward rounds.

Entered SOAP notes on electronic medical records.

Participated in educational sessions and delivered several PowerPoint presentations on medical topics of interest.

Wrote and edited for medical education companies and physicians.

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