Vicki Sudan
Denver,CO
Summary
Accomplished Clinical Research Coordinator skilled in clinical trial management and patient care coordination. Expertise in protocol development and regulatory compliance, with strong analytical and communication skills. Focused on advancing research methodologies and improving participant recruitment strategies.
Overview
29
29
years of professional experience
Work History
Clinical Research Coordinator
Apex Dermatology
Denver, CO
01.2016 - Current
- Coordinated clinical trial activities to ensure compliance with regulatory guidelines.
- Managed patient recruitment and informed consent processes, enhancing participant engagement for multiple studies.
- Developed and maintained study documentation, including protocols and reports.
- Collaborated with investigators to implement study protocols efficiently.
- Scheduled and facilitated participant visits, ensuring adherence to timelines and optimizing study flow.
- Executed research activities for skin study BMX-derm-01, contributing to data collection and analysis.
Clinical Research Coordinator
The Mile High Research Center
Denver, CO
01.2015 - Current
- Alzheimer’s Disease: Administer rating scales for studies: Eisai E2609-G000-301, Eli Lilly D5010C0009, Tau Rx TRx-237-005, Tau Rx TRx-237-020, Roche: Crenezumab study BN29552, AZTherapies: AZT-001, Avid Radiopharmaceuticals: 18F-AV-45-A25, AgeneBio: AGB101 MCD, Eisai BAN2401-G000-301, Athira Pharma ATH-1017-AD-0201, Novo Nordisk NN6535-4725, T3D Therapeutics T3D959-202, Actinogen ACW0009, Cognito Therapeutics CA-0015, Cognito Therapeutics CA-0011, Episodic Migraine: Eli Lilly 15Q-MC-CGAG
- Coordinated clinical trials for dermatological treatments and products.
- Managed patient recruitment and retention for research studies.
- Oversaw regulatory compliance and documentation for clinical protocols.
Clinical Research Coordinator
Dr. Jack A. Klapper
Denver, CO
01.2016 - 01.2017
- Managed patient recruitment and informed consent processes for multiple studies.
- Collaborated with investigators to implement study protocols efficiently.
- Coordinated clinical trial activities, ensuring adherence to regulatory guidelines for successful study execution.
- Reviewed CRFs for completeness and accuracy, facilitating timely and accurate database entry.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results.
Clinical Research Coordinator
Horizons Clinical Research Center
Denver, CO
01.2015 - 09.2015
- Coordinated clinical trial activities, ensuring adherence to regulatory guidelines and study integrity.
- Managed patient recruitment and informed consent processes for multiple studies.
- Engaged potential subjects to enhance recruitment for clinical studies.
- Obtained informed consent from subjects prior to study participation.
- Perform study/protocol procedures in a detailed, accurate manner
- Track subjects, avoiding lost to follow up
- Documented adverse events, detailing event descriptions, severity, and frequency for compliance and safety monitoring.
- Developed and maintained study documentation, including protocols and reports.
- Collaborated with investigators to implement study protocols efficiently.
- Monitored data collection for accuracy and completeness throughout studies.
Medical Doctor Research Assistant
STAR Center Sensory Therapies & Research
Greenwood Village, CO
05.2014 - 01.2015
- Assessed children with neurological, motor, and behavioral concerns, including SPD, ADHD, Autism Spectrum Disorder, and communication disorders, to inform treatment strategies.
- Collaborated in multidisciplinary meetings to evaluate and enhance patient treatment plans.
- Produced video clips of therapy sessions for occupational therapists, psychologists, and pediatricians to support patient assessment and treatment planning.
- Observed mental health family services team as they assessed and provided support to children.
- Sensory Therapies & Research: Sensory Processing Disorder Foundation.
Research Fellow
Icahn Medical Institute. Mount Sinai School of Medicine
New York City, NY
12.2012 - 03.2013
- Collected data from over 600 patients who came to sperm bank program at the Andrology Laboratory over the last 15 years.
- Reviewed patient data concerning cryopreservation of semen before undergoing radiation or chemotherapy treatments for cancer.
- Conducted a large retrospective study to assess the role of sperm banking with patients with cancer.
- Retrieved and organized patient laboratory results and clinical charts into a systematic spreadsheet database.
- Meticulous, dedicated and focused in understanding the importance of sperm banking in patients with cancer who may become sterile following the treatment of their cancers.
Research Fellow
Cleveland Clinic Andrology Laboratory
Cleveland, OH
06.1997 - 08.1997
- Cleveland Clinic Foundation for the Center for Advanced Research in Human Reproduction and Infertility of Urological Institute.
- Expertise in lab and field research, data collection/analysis and project management.
- Created comprehensive reports summarizing laboratory data, supporting informed decision-making.
- Accurately recorded and reported test results according to established procedures.
- Recorded control values from technical instruments, enhancing reliability and accuracy of test result reporting.
- Referred quality control data to the Clinical Laboratory Scientist Coordinator.
- Demonstrated self-motivation by initiating projects independently.
- Mastered the art of time management, organization and record keeping.
- Promptly and efficiently distributed specimens to different facilities and labs.
Education
M.D. - Medical Course Work (behavioral Sciences)
Emory Medical Hospital
Basseterre, St. Kitts01-2008
Doctor of Medicine -
Windsor University School of Medicine
Atlanta, GABachelors of Arts Degree -
McMaster University
Hamilton, ONT, CanadaSkills
- Clinical trial expertise
- Protocol development
- Protocol review
- Regulatory compliance
- Informed consent
- Subject recruitment
- Care coordination
- Trial management
- Electronic data capture
- Event reporting
- Participant screening
- Data interpretation
- Research methodology
- Planning research
- Records management
- Research expertise
- Analytical skills
- Lab practices
- Team collaboration
- Interpersonal communication
- Research expertise
Publications
- Hallak, J., Kolettis, P., Sekhon, V., Thomas, A.J., Jr., and Agarwal, A., Cryopreservation of sperm from patients with leukemia: is it worth the effort?, Cancer, 85, 1973-1978, 1999
- Hallak, J., Kolettis, P.N., Sekhon, V.S, Thomas, A.J., Jr., and Agarwal, A., Sperm Cryopreservation in patients with leukemia: is it worth the effort?, 54th Annual Meeting of the American Reproductive Medicine, San Francisco, CA, 10/04-09/98, #256
- Hallak, J., Kolettis, Sekhon, V.S, Thomas, A.J., Jr., and Agarwal, A., Prefreeze and postthaw semen quality in men with testicular cancer., 54th Annual Meeting of the American Reproductive Medicine, San Francisco, CA, 10/04-09/99, #174
Timeline
Clinical Research Coordinator
Dr. Jack A. Klapper
01.2016 - 01.2017
Clinical Research Coordinator
Apex Dermatology
01.2016 - Current
Clinical Research Coordinator
Horizons Clinical Research Center
01.2015 - 09.2015
Clinical Research Coordinator
The Mile High Research Center
01.2015 - Current
Medical Doctor Research Assistant
STAR Center Sensory Therapies & Research
05.2014 - 01.2015
Research Fellow
Icahn Medical Institute. Mount Sinai School of Medicine
12.2012 - 03.2013
Research Fellow
Cleveland Clinic Andrology Laboratory
06.1997 - 08.1997
M.D. - Medical Course Work (behavioral Sciences)
Emory Medical Hospital
Doctor of Medicine -
Windsor University School of Medicine
Bachelors of Arts Degree -
McMaster University