Coordinate FDA regulated clinical trials involving alcohol, opioids, and cannabis investigational products.
Determine eligibility of prospective participants for various research studies.
Follow informed consent processes and maintained accurate documentation records.
Process and store blood samples obtained from participants according to processing protocol.
Carry out participant study appointments which includes administering various assessments and questionnaires, assessing cognitive functioning and psychological functioning, providing compensation, and more.
Maintain compliance with protocols covering clinical trial operations.
Appropriately store, dispense, and log inventory of investigational products.
Coordinate research tasks between participants, other coordinators, wet lab manager, clinical laboratory, and the Clinical and Translational Research Center.
Utilize EDC platform REDCap for data entry and analysis according to standard operations manual while simultaneously checking for validity and accuracy.
Create surveys and questionnaires to collect data for research projects within EDC platform REDCap.
Utilize EPIC for Electronic Medical Records review.
Create and submit protocol and consent form amendments, minor modifications, study personnel changes, and patient facing document revision to IRB using electronic research administration systems.
Experience with study start-up including conducting literature reviews, protocol development and drafting, consent form drafting, completing IRB application for protocol review, building data entry projects within EDC system, creating SOPs, creating internal tracking documents, creating training slides, and more.
Utilize R Studio for data analysis.
Utilize various applications such as Microsoft Word, PowerPoint, Excel, and Access as well as Mendeley Reference Manager.
Presented research poster of preliminary study results at the Department of Psychiatry's 2023 poster session.
Skilled at working independently and collaboratively in a team environment.
Clinical Research Coordinator
University Of Colorado Anschutz Medical Campus
07.2021 - 05.2022
Worked alongside Hematologists to educate, consent, and enroll patients into various industry and investigator sponsored clinical research studies.
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.
Followed informed consent processes and maintained records.
Performed data entry and continuously updated databases and files with new information while simultaneously checking for validity and accuracy.
Processed and prepared patient blood samples to be sent out to various laboratories for testing.
Aided with other various research related projects when needed.
Utilized REDCap, Microsoft applications, as well as industry-sponsored websites for data collection.
Utilized the Electronic Medical Chart software EPIC to gather data and perform medical chart reviews.
Undergraduate Research Assistant
University Of Colorado Boulder
06.2020 - 12.2020
Administered confidential surveys and assessments to participants during participant appointment and ensured completion according to protocol.
Recorded data and maintained source documentation following good documentation practices.
Utilized REDCap software to administer surveys and assessments.
Scheduled appointments with test subjects over phone and through email.
Assessed initial eligibility surveys to determine participant's eligibility according to protocol.
Reported data and study progress to the Principal Investigator.
Education
Bachelor of Arts - Molecular, Cellular and Developmental Biology
University Of Colorado Boulder
Boulder, CO
12.2020
Bachelor of Arts - Neuroscience
University Of Colorado Boulder
Boulder, CO
12.2020
Skills
Laboratory skills including centrifuging, aliquoting, red blood cell isolation, and DNA isolation
Microsoft Excel, PowerPoint, Word and Access
EDC REDCap platform skills
Human subject research
Blood processing
IRB submissions
Electronic Medical Record reviews
Data collection, entry, analysis
R studio skills
Good Clinical Practice
Research poster presentations
Research protocol development
Study start-up
Medication dispensing
Adverse event documentation
Informed consent
Participant recruitment
Database organization
Potential subject evaluation
Timeline
Clinical Research Coordinator
University Of Colorado Anschutz Medical Campus
05.2022 - Current
Clinical Research Coordinator
University Of Colorado Anschutz Medical Campus
07.2021 - 05.2022
Undergraduate Research Assistant
University Of Colorado Boulder
06.2020 - 12.2020
Bachelor of Arts - Molecular, Cellular and Developmental Biology
Instructor of Pediatric Surgery, PNP-AC at University Of Colorado Anschutz Medical CampusInstructor of Pediatric Surgery, PNP-AC at University Of Colorado Anschutz Medical Campus
Professional Research Assistant at University Of Colorado Anschutz Medical CampusProfessional Research Assistant at University Of Colorado Anschutz Medical Campus
Registered Nurse, Acute Care Float Pool at University Of Colorado Anschutz Medical CampusRegistered Nurse, Acute Care Float Pool at University Of Colorado Anschutz Medical Campus