Versatile clinical research professional knowledgeable about coordinating Oncoclogy patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
10
10
years of professional experience
Work History
Quilt Shop Owner
Quilted Buffalo
04.2022 - Current
Boosted customer satisfaction by providing exceptional service and addressing any concerns promptly.
Increased store revenue through effective product merchandising and targeted marketing campaigns.
Developed loyal customer base by consistently delivering high-quality products and personalized service.
Clinical Research Associate
Synteract
06.2021 - 03.2022
Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Temporary Clinical Research Associate
ICON Government and Public Health Solutions
07.2020 - 05.2021
Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
Clinical Research Associate
Merck
09.2017 - 06.2020
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
Clinical Research Associate
PRA Embedded in Merck
07.2015 - 09.2017
Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Clinical Research Coordinator
University of Nebraska Medical Center
11.2013 - 06.2015
Gathered, processed, and shipped lab specimens.
Maintained compliance with protocols covering patient care and clinical trial operations.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
Education
BSN -
Pacific Lutheran University
01.1993
Skills
Research Experience
Good Clinical Practices
Specimen Handling
Medication Dispensing
Informed Consent
Trial Management
Study Protocols
Documentation Requirements
Phlebotomy
Research SOPs Understanding
Participant Screening
Schedule Coordination
Therapeutic Areas Of Expertise
Oncology, Solid Tumors
Personal Information
Title: CRA, BSN
Training
Barnett CRA Beginner Program, 08/11/15 University of California San Diego: Monitoring Clinical Trials Course, 08/19/15