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. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Conduct monitoring visits to verify compliance with protocol, ICF- procedures, Regulatory standards, SOP, and ICH-GCP as needed
Comprehend and familiarize oneself with study protocol to be prepared to provide training to staff as required
Write visit reports, corresponding site confirmations, and follow-up letters for all visit types.
Review electronic case report form data collection systems for accuracy, monitor for data completeness, and identify any implausible entries.
Worked closely with other clinical team members to ensure timely resolution and closure of data queries.
Maintain comprehensive documentation of all site correspondence
Provide necessary materials and instructions to ensure proper implementation of study Protocol.
Perform source document verification, source data review, and review of regulatory documents and IP as outlined in monitoring plan.
Escalate issues within clinical Operations team as needed.
Enhance data quality by closely monitoring study progress and ensuring accurate data collection.
Facilitate timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Maintain strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
Maintain comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
Follow informed consent processes and maintained records.
Maintain compliance with protocols covering patient care and clinical trial operations.
Review participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Facilitate quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Clinical Research Coordinator II (Migraine, Asthma and COPD)
DM Clinical Research
03.2023 - 12.2023
Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
Trained new team members on essential clinical research protocols and procedures, promoting culture of continuous learning.
Reduced data entry errors by implementing stringent quality control measures throughout study lifecycle.
Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
Assessed more than 2000 patients' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
Contributed to successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in fast-paced environment.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Followed informed consent processes and maintained records.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Gathered, processed, and shipped lab specimens.
Maintained compliance with protocols covering patient care and clinical trial operations.
Streamlined data collection processes for increased efficiency and accuracy in study results.
Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
Graduate Research Assistant
CENTRAL MICHIGAN UNIVERSITY
08.2019 - 09.2021
Learned how to tackle challenging issues that affect communities.
Worked with people across sectors and educated public about best health care practices.
Assisted in implementing public health programs to address concerns that affect diverse populations.
Enhanced research quality by conducting thorough literature reviews and synthesizing findings.
Streamlined data analysis processes for improved efficiency and accuracy in research results.
Mentored approximately 25 undergraduate students, providing guidance on research methodologies and techniques.
Managed multiple research projects simultaneously, ensuring timely completion and adherence to high-quality standards.
Presented research findings at conferences and workshops, fostering professional growth and collaboration within academic community.
Utilized advanced statistical software to analyze large datasets, uncovering key insights for informed decision making.
Participated in regular meetings with project supervisors, providing progress updates and discussing potential challenges or areas for improvement.
Designed surveys and interview protocols for primary data collection, ensuring accurate representation of target populations.
Reviewed and synthesized relevant research articles to inform development of research questions and hypotheses.
Completed administrative and research duties per professor request.
Performed statistical, qualitative, and quantitative analysis.
Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using SPSS.
Conducted thorough literature reviews to better understand research topics and prepare for studies.
Followed health and safety regulations while handling dangerous or toxic substances.
Performed experiments and conducted research to study impacts of pollution on animal and plant species.
Reviewed technical and professional publications and journals to stay current on recent literature and make more strategic research decisions.
Volunteering
VIRAL SOLUTIONS
06.2021 - 08.2021
Patient check-in, consenting, taking vitals and data entry.
COVID-19 screening.
Assisted in planning and execution of company events, resulting in increased employee engagement and satisfaction.
Utilized strong communication abilities during presentations which led to increased understanding among colleagues regarding project goals and objectives.
Prepared written summaries of meeting discussions to ensure clear communication throughout team while promoting accountability for action items.
Analyzed problems and worked with teams to develop solutions.
Provided exceptional customer service by promptly addressing inquiries, ensuring high level of satisfaction among clientele.
Enhanced intern productivity by assisting with project coordination and providing ongoing support.
Clinical Research Coordinator
CENTRAL MICHIGAN UNIVERSITY
08.2019 - 05.2021
Documented patient assessments, observations, test results and other study related information per ALCOA-C guidelines.
Documented outstanding action items with expected completion dates and timeline.
Scheduled study visits for research subjects according to study protocol
Screened over 500 patient records and physician referrals to identify prospective candidates for research studies.
Following inclusion and exclusion criteria
Ensured compliance with all federal and local agencies including Food and Drug Administration (FDA) and Institutional Review Board (IRB)
Maintained research practices using Good Clinical Practice (GCP) guidelines.
Maintained strict patient confidentiality according to HIPAA regulations.
Coordinates all aspects of study including recruitment, consent, screening, scheduling, and tracking and provides study updates to study participants throughout conduct of study.
Improved recruitment rates by developing and implementing effective patient outreach strategies.
Clinical Research Coordinator
ARENSIA EXPLORATORY MEDICINE
04.2017 - 06.2019
Recruited over 70 patients for research studies with knowledge of protocol defined inclusion/exclusion criteria.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Scheduled and conducted patient visits according to protocol requirements and timeline.
Documentation of patient visits and protocol related activities following ALCOA-C guidelines
Reported AEs and SAEs to Principal Investigator and sponsor in timely manner.
Maintained inventory of investigational drugs and/or devices
Collected and entered data into study case report forms and/or electronic data capture system (EDC) and responded to queries in timely manner.
Followed informed consent processes and maintained records.
Organized and participated in monitoring visits.
Maintained compliance with protocols covering patient care and clinical trial operations.
Education
No Degree - Clinical Research Associate
The CRA ACADEMY
San Bernardino, CA
04.2023
Master Of Public Health - Public Health
Central Michigan University
Mount Pleasant
03.2022
M.D. - Medicine
Petre Shotadze Tbilisi Medical Academy
Tbilisi, Georgia
02.2019
Skills
Excellent verbal written communication skills, and Strong attention to detail
Strong analytical skills and ability to resolve problems efficiently
Microsoft Office applications: Outlook, Word, Excel, and PowerPoint
Coordinating site operations, Site monitoring, and Protocol adherence
Electronic Data Capture (EDC), Data Collection, and Case Report Forms
Detailed documentation, Source Document Verification
Drug Accountability
Patient recruitment, Patient Safety, and Adverse event reporting
Team Training and Protocol Review
Informed Consent Process, and Participant screening
ICH-Good Clinical Practices, Study protocol, and Research SOPs understanding
Interpersonal and Organizational Skill
Teamwork, Collaboration, Multitasking and Task Prioritization
Self-Motivation and Continuous Improvement
Adaptability and Flexibility, Reliability and
Time Management
Certification
ICH-GCP and IATA Certified
Technical Competence
EDC: Bio clinical, Medidata Rave, Med Net, CRIO, Inform, Florence
EMR and IRB: Epic, Secure Consent, Complion, Advarra, and Connexus