Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines. Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in Clinical Research.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Krishna Institute of Medical Sciences
06.2024 - Current
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Followed informed consent processes and maintained records.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Monitored patient safety throughout clinical trials and reported any adverse events.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Developed and maintained accurate and up-to-date case report forms and source documents.
Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Maintained accurate and up-to-date case report forms and source documents for traceability.
Facilitated focus group sessions with project patients.
Prepared and maintained regulatory documents for clinical trial submissions.
Complied with research protocols by providing ongoing quality control audits.
Collected, evaluated, and modeled collected data.
Internship Student
AUROBINDO PHARMA PVT LTD
05.2019 - 06.2019
Sorted, organized, and maintained files.
Sorted and organized files, spreadsheets, and reports.
Prepared project presentations and reports to assist senior staff.
Explored new technologies and approaches to streamline processes.
Developed and maintained quality assurance procedure documentation.
Created and revised procedures, checklists and job aids to reduce errors.
Performed routine maintenance and calibration on testing equipment.
Collected and analyzed data to measure effectiveness of quality control processes.
Education
MASTERS IN PHARMACY - PHARMACEUTICAL ANALYSIS
SRM COLLEGE OF PHARMACY
Chennai, India
06.2022
BACHELOR OF PHARMACY - Pharmaceutical Sciences
GITAM INSTITUTE OF PHARMACY
Visakhapatnam, India
04.2020
Skills
Research SOPs understanding
Phlebotomy
Good Clinical Practices
Informed consent
Trial management
Research experience
Participant screening
Documentation requirements
Site Management
Schedule Coordination
Records Maintenance
Data Analysis
Specimen handling
Specimen collections
Certification
Certified in "GOOD CLINICAL PRACTICES (ICH GCP E6R2 GUIDELINES),ICMR 2017, AND NEW DRUG CLINICAL TRAIL REGULATIONS" Conducted by Quinary Clinical Reseach Pvt, Ltd. - June 12th, 2024
Certified in Good Clinical Practice by NIDA CLINICAL TRAILS NETWORK [5Th October 2024 - 5th October 2027]
Hobbies
Reading,
hiking,
photography,
cricket,
volleyball,
chess,
traveling.
Languages
English
Upper intermediate (B2)
Telugu
Advanced (C1)
Hindi
Intermediate (B1)
Timeline
Clinical Research Coordinator
Krishna Institute of Medical Sciences
06.2024 - Current
Internship Student
AUROBINDO PHARMA PVT LTD
05.2019 - 06.2019
MASTERS IN PHARMACY - PHARMACEUTICAL ANALYSIS
SRM COLLEGE OF PHARMACY
BACHELOR OF PHARMACY - Pharmaceutical Sciences
GITAM INSTITUTE OF PHARMACY
Certified in "GOOD CLINICAL PRACTICES (ICH GCP E6R2 GUIDELINES),ICMR 2017, AND NEW DRUG CLINICAL TRAIL REGULATIONS" Conducted by Quinary Clinical Reseach Pvt, Ltd. - June 12th, 2024
Certified in Good Clinical Practice by NIDA CLINICAL TRAILS NETWORK [5Th October 2024 - 5th October 2027]
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