Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Cynthia Antonio-Drabek

Coal Valley,IL

Summary

Adept at data management and fostering investigator relations, I significantly enhanced clinical trial efficiency and compliance at IQVIA. My expertise in regulatory documentation and organizational capabilities led to a marked improvement in study outcomes, with a focus on achieving results through meticulous attention to detail and proactive problem-solving. Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Hardworking CRA successfully leads site evaluations, initiations and closeouts. Well-versed in different therapeutic trials and of picks up new procedures quickly. Offering advanced planning, problem-solving and communication skills developed over 12+ years of clinical research success. Knowledgeable CRA is adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. 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.

Overview

46
46
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Associate

IQVIA
08.2012 - 03.2024
  • Conducted selection, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Communicated project status to Global Project Managers. Clinical Team Lead and management verbally and through technical documentation and presentations.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
  • Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
  • Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • 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.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Followed informed consent processes and maintained records.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • 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.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.

Lead Study Coordinator

Trinity Medical Center
02.2002 - 08.2012
  • Supported participant retention efforts by designing engaging materials that highlighted the benefits of continued involvement in the study.
  • Streamlined communication between participants and research team, fostering effective collaboration and data collection.
  • Enhanced interdisciplinary collaboration among researchers by organizing regular team meetings and progress updates.
  • Promoted a culture of continuous improvement within the research team through constructive feedback on study processes and outcomes.
  • Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
  • Expedited study start-up timelines by efficiently coordinating site initiation visits, trainings, and equipment setup.
  • Improved data accuracy by implementing rigorous quality control measures during data collection and entry processes.
  • Facilitated timely enrollment of participants through targeted recruitment strategies.
  • Contributed to a positive work environment by fostering open communication, teamwork, and professional development opportunities for staff members.
  • Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
  • Maintained up-to-date knowledge of industry best practices, regulations, and advancements in clinical research coordination methodologies.
  • Strengthened relationships with external partners such as clinical sites and vendors through effective communication channels and consistent follow-through on commitments.
  • Ensured regulatory compliance by meticulously maintaining documentation for study activities.
  • Contributed to successful grant applications by assisting with proposal preparation, submission, and follow-up activities.
  • Optimized resource allocation for the research project, effectively managing budgets and personnel requirements.
  • Mitigated risks to study integrity through vigilant monitoring of protocol adherence and prompt resolution of any deviations.
  • Reduced study attrition rates by proactively addressing participant concerns and providing ongoing support.
  • 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.
  • 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.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.

Study Coordinator-

Michael Reese Hospital & Medical Center
06.1995 - 01.2001
  • Enhanced interdisciplinary collaboration among researchers by organizing regular team meetings and progress updates.
  • Supported participant retention efforts by designing engaging materials that highlighted the benefits of continued involvement in the study.
  • Maintained up-to-date knowledge of industry best practices, regulations, and advancements in clinical research coordination methodologies.
  • Mitigated risks to study integrity through vigilant monitoring of protocol adherence and prompt resolution of any deviations.
  • Ensured regulatory compliance by meticulously maintaining documentation for study activities.
  • Reduced study attrition rates by proactively addressing participant concerns and providing ongoing support.
  • Facilitated timely enrollment of participants through targeted recruitment strategies.
  • Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
  • Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
  • Expedited study start-up timelines by efficiently coordinating site initiation visits, trainings, and equipment setup.
  • Optimized resource allocation for the research project, effectively managing budgets and personnel requirements.
  • Improved data accuracy by implementing rigorous quality control measures during data collection and entry processes.
  • Contributed to a positive work environment by fostering open communication, teamwork, and professional development opportunities for staff members.
  • 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.
  • 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.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.

Assistant Nurse Manager- Coronary Care Unit

Michael Reese Hospital & Medical Center
03.1978 - 01.1995
  • Performed real-time chart audits for patients ensuring accuracy and completeness of information while capitalizing on opportunities for process improvement.
  • Resolved conflicts among staff members by employing effective communication techniques and seeking mutually beneficial solutions when issues arose.
  • Evaluated staff performance regularly, providing constructive feedback and support for professional development opportunities.
  • Managed scheduling to ensure optimal coverage while maintaining a healthy work-life balance for staff members.
  • Collaborated with other departments to streamline processes and enhance interdisciplinary teamwork, ultimately improving continuity of care for patients.
  • Participated in hospital-wide initiatives aimed at improving overall patient experience and satisfaction levels.
  • Ensured timely documentation of all nursing activities within electronic medical records system, contributing to accurate record keeping and informed decision-making processes.
  • Maintained open lines of communication with patients'' families to ensure their needs were met and concerns addressed promptly.
  • Served as a liaison between nursing staff and administration, advocating for the needs of both parties to promote overall organizational success.
  • Communicated with members of medical staff and department heads during weekly update meetings.
  • Created work schedules for multiple shifts to confirm complete floor coverage.
  • Maintained compliance with regulatory standards by staying up-to-date on industry best practices and incorporating them into daily operations as necessary.
  • Promoted a positive work environment by fostering open communication, teamwork, and professional growth opportunities for nursing staff.
  • Improved patient safety through close monitoring of infection control practices within the department.
  • Streamlined nursing operations for efficiency and quality improvement by conducting regular audits and addressing areas of concern.
  • Integrated evidence-based nursing into practice environment for [Number] nurses.
  • Verified facility remained up-to-date and compliant with laws and regulations.
  • To reduce hospital-acquired infections, falls, and medication errors for improved patient safety.
  • Assisted Nurse Manager.
  • Supervised, directed, and motivated high-quality performance from nursing staff.
  • Increased patient satisfaction by implementing individualized care plans and coordinating with interdisciplinary teams.
  • Streamlined steps in rapid response situations by prioritizing and delegating tasks.
  • For nursing students, providing mentorship to help them develop critical thinking and clinical skills.
  • Kept organized records of facility's services and utilization of inpatient beds.
  • Established and continuously optimized unit schedules and individual work assignments.
  • Developed and implemented quality improvement initiatives to provide best possible patient care and identify and address areas of concern.
  • Evaluated skills of nursing personnel and verified staff certifications for validity.
  • Trained new nurses in proper techniques, care standards, operational procedures, and safety protocols.
  • Developed strategy to target nursing and patient satisfaction issues, improve response, and patient care quality and suggest actionable improvements to promote hospital-wide quality and safety initiatives.
  • Fostered improvement in staff development, personnel training, and standards of patient care.
  • Managed staff scheduling and time off to adequately staff nursing floors and allow nurses earned time off.
  • Investigated and independently resolved complaints from staff, physicians, and patients by leveraging clinical judgment and unit management expertise.
  • Reviewed patient transfer records routinely to verify patients received appropriate levels of care.
  • Promoted professional development opportunities to encourage nurses to pursue continuous training.
  • Managed 25 nurses and nursing activities in 12-CCU bed hospital by providing comprehensive nursing guidance and maintaining outstanding patient satisfaction and care standards.
  • Worked at least 80 hours per month as floor nurse to maintain clinical proficiency.
  • Oversaw infection control procedures to protect patients from infections and keep nursing departments compliant with state regulations.
  • Established and maintained effective communication with staff, physicians and community organizations to promote high quality patient care.
  • Monitored and inspected staff processes to eliminate hazards posed for both residents and staff while ensuring continuous compliance with regulations.
  • Liaised with other healthcare professionals to develop comprehensive patient care plans and provide highest quality of care.
  • Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, benefits administration and general liability.
  • Communicated with patients, ensuring that medical information was kept private.
  • Created customized care plans, working with hospital staff and families to assess and meet individual needs.
  • Ordered all pharmacy supplies and kept check on inventory levels.

Education

Bachelor of Science - Nursing

University of The Philippines, College of Nursing
Quezon City, Philippines
05.1974

Skills

  • Data Management Proficiency
  • Coordinating site operations
  • Informed Consent Process
  • Adverse event reporting
  • Quality Assurance Techniques
  • Clinical trial management
  • Vendor Management Experience
  • Completing regulatory documents
  • Therapeutic Area Expertise
  • Site Management
  • Organizational capabilities
  • Investigator relations
  • Regulatory Compliance Knowledge
  • Clinical Study Design
  • Report Writing
  • Action planning
  • Medical terminology fluency
  • Coordinating supplies
  • Site monitoring expertise
  • Pharmacovigilance principles
  • Study documentation mastery
  • ICH-GCP guidelines
  • Electronic Data Capture Systems
  • Good Clinical Practices
  • Study protocols
  • Patient recruitment
  • Research SOPs understanding
  • Data collection techniques
  • Informed consent
  • Specimen handling
  • Medication Dispensing
  • Research experience
  • Trial management
  • Participant screening
  • Documentation requirements
  • Schedule Coordination
  • Scheduling proficiency
  • Records Maintenance
  • Documentation Management
  • Report Preparation
  • Quality Assurance
  • Records Management
  • Clinical trial expertise
  • Protocol Review
  • Disease Research

Certification

GCP Certified

Medidata Certificate Trained

RN Licensed Illinois


Languages

Spanish
Limited Working
Tagalog
Native or Bilingual

Timeline

Senior Clinical Research Associate

IQVIA
08.2012 - 03.2024

Lead Study Coordinator

Trinity Medical Center
02.2002 - 08.2012

Study Coordinator-

Michael Reese Hospital & Medical Center
06.1995 - 01.2001

Assistant Nurse Manager- Coronary Care Unit

Michael Reese Hospital & Medical Center
03.1978 - 01.1995

Bachelor of Science - Nursing

University of The Philippines, College of Nursing

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Cynthia Antonio-Drabek