Kathia E. Pena
Apex,NC
Summary
Proven achiever in clinical research coordination at UNC Chapel Hill School of Medicine, I excel in streamlining data collection and enhancing patient safety, evidenced by improved recruitment rates and participant retention. Skilled in Electronic Data Capture and 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. My approach has consistently led to the successful completion of trials and notable efficiency gains.
Overview
25
25
years of professional experience
Work History
Social/Clinical Research Coordinator
UNC Chapel Hill School of Medicine
03.2016 - Current
- Followed clinical research protocols and conducted study visits in compliance with regulations.
- Screened patient records, databases, and physician notes to identify prospective candidates for research studies.
- Gathered, processed, and shipping lab specimens.
- 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.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- 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.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Collected, evaluated, and modeled collected data.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Social/Clinical Research Assistant
UNC Chapel Hill School of Medicine
10.2009 - 02.2016
- Participated in site monitoring visits, addressing any concerns or discrepancies related to patient enrollment or data collection procedures.
- Monitored safety events during clinical trials by promptly reporting adverse events and implementing corrective action plans as needed.
- Maintained up-to-date knowledge of industry regulations by attending professional development trainings and reviewing data regularly.
- Educated patients regarding all facets of clinical study participation.
- Facilitated efficient organization of study-related documents through meticulous record-keeping practices.
Social/Clinical Research Assistant
UNC Chapel Hill School of Medicine
01.2006 - 09.2008
- Participated in site monitoring visits, addressing any concerns or discrepancies related to patient enrollment or data collection procedures/specimens.
- Monitored safety events during clinical trials by promptly reporting adverse events and implementing corrective action plans as needed.
- Maintained up-to-date knowledge of industry regulations by attending professional development trainings and reviewing data regularly.
- Educated patients regarding all facets of clinical study participation.
- Facilitated efficient organization of study-related documents through meticulous record-keeping practices.
Counselor/Medical Interpreter
Raleigh Womens Health Organization
01.2000 - 12.2005
- Assisted patients for medical procedures. Interpreting, counseling and assisted Spanish speaker patients.
- Maintained accurate documentation of client for procedures performed.
- Educated patients for post procedures care and follow up visit.
Education
Certificate of Medical Interpreter - Language Interpretation And Translation
NBCMI
Raleigh, NC06.2009
Phlebotomy Certificate - Health Management And Clinical Assistance
Wake Technical Community College
Raleigh, NC05.2007
Master of Science - Economy
National University of Nicaragua
Managua-Nicaragua03.1994
Bachelor of Science - Agricultural Engineering
National Engineering University
Nicaragua03.1992
Skills
- Good Clinical Practices and Follow Study Protocols
- Electronic Data Capture, Data Collection and Analysis
- Informed Consent and Process
- Participant screening and Patient recruitment
- Research experience and Multitasking
- Records Management and Maintenance
- Phlebotomy
- Site Management and Goal Setting
- Time Management and Schedule Coordination
- Adverse event reporting
- Medication Dispensing and specimen handling and collection
- Teamwork, Collaboration, Adaptability and Professionalism
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
Social/Clinical Research Coordinator
UNC Chapel Hill School of Medicine
03.2016 - Current
Social/Clinical Research Assistant
UNC Chapel Hill School of Medicine
10.2009 - 02.2016
Social/Clinical Research Assistant
UNC Chapel Hill School of Medicine
01.2006 - 09.2008
Counselor/Medical Interpreter
Raleigh Womens Health Organization
01.2000 - 12.2005
Certificate of Medical Interpreter - Language Interpretation And Translation
NBCMI
Phlebotomy Certificate - Health Management And Clinical Assistance
Wake Technical Community College
Master of Science - Economy
National University of Nicaragua
Bachelor of Science - Agricultural Engineering
National Engineering University
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