Accomplished Lead Clinical Research Coordinator with a proven track record at Miray Medical Research, enhancing patient safety and trial efficiency. Expert in electronic data capture and fostering a culture of continuous improvement. Achieved significant advancements in clinical research through innovative protocol development and meticulous adherence to guidelines.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Wagner Kapoor Reseach Institute
03.2024 - Current
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Gathered, processed, and shipped lab specimens.
Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Followed informed consent processes and maintained records.
Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Maintained compliance with protocols covering patient care and clinical trial operations.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
Developed and maintained accurate and up-to-date case report forms and source documents.
Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
Maintained accurate and up-to-date case report forms and source documents for traceability.
Monitored patient safety throughout clinical trials and reported any adverse events.
Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.
Reviewed referral information and kept track of intakes from various referral sources.
Lead Clinical Research Coordinator
Miray Medical Research
01.2011 - 09.2013
Increased patient safety with diligent monitoring, prompt adverse event reporting, and thorough follow-up investigations.
Promoted a culture of continuous improvement within the research team by regularly identifying areas for growth and implementing new best practices or tools as needed.
Contributed to scientific advancements through participation in conferences, publication of research findings in peer-reviewed journals, and collaboration on multidisciplinary projects.
Supported principal investigators in developing innovative research ideas into feasible clinical protocols aligned with organizational goals.
Optimized resource allocation for efficient trial operations by closely tracking project milestones and adjusting staffing levels accordingly.
Mentored junior clinical research coordinators in best practices for trial management, fostering professional development and growth within the team.
Maximized protocol compliance by providing comprehensive training to research staff and ensuring adherence to guidelines.
Enhanced patient enrollment by streamlining the recruitment process and strengthening relationships with referral sources.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Maintained compliance with protocols covering patient care and clinical trial operations.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Monitored patient safety throughout clinical trials and reported any adverse events.
Maintained accurate and up-to-date case report forms and source documents for traceability.
Prepared and maintained regulatory documents for clinical trial submissions.
Reviewed referral information and kept track of intakes from various referral sources.
Complied with research protocols by providing ongoing quality control audits.
Developed and maintained accurate and up-to-date case report forms and source documents.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Gathered, processed, and shipped lab specimens.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Reduced study deviations through meticulous documentation of informed consent processes, eligibility assessments, and visit details.
Education
Medical Assistant Certification - Medical Assistant
Bryman Institute
Boston, MA
03-2008
Skills
Good clinical practices
Electronic data capture
Documentation management
Informed consent
Adverse event reporting
Study protocols
Informed consent process
Patient recruitment
Investigational product management
Research sops understanding
Research experience
Documentation requirements
Phlebotomy
Certification
Medical Assistant Certification 2008
Good Clinical Practice (GCP) Certification - Various Providers.
HIPAA Compliance Training Certificate – Various Accredited Providers.
First Aid Certification
OSHA Certified
IATA Certified
Timeline
Clinical Research Coordinator
Wagner Kapoor Reseach Institute
03.2024 - Current
Lead Clinical Research Coordinator
Miray Medical Research
01.2011 - 09.2013
Medical Assistant Certification 2008
Good Clinical Practice (GCP) Certification - Various Providers.
HIPAA Compliance Training Certificate – Various Accredited Providers.
First Aid Certification
OSHA Certified
IATA Certified
Medical Assistant Certification - Medical Assistant
Bryman Institute
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