CATHLIN (KIT) ROOD
Redwood City,CA
Summary
Dynamic healthcare professional with 7+ years in fast-paced, competitive clinical research, both at the academic and pharmaceutical level. Looking for a senior clinical trials associate role with an emphasis in data integrity, quality assurance and site management.
Overview
10
10
years of professional experience
Work History
Clinical Trials Management Associate
Gilead Sciences
09.2022 - 04.2024
- Coordinated Important Protocol Deviation alignment across all Gilead Trodelvy studies to ensure all similar protocol deviations are codified uniformly across 5 different trials
- Acted as the primary vendor lead overseeing CROs, imaging, central labs, and EDC vendors
- Led cross-functional IPD meetings and oversaw documentation of all IPDs (North America, APAC, Europe) including performing safety risk assessments and process refinement
- Created protocol-adherent clinical project documents including, but not limited to: source documentation forms and guidelines, eCRFs, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports
- Implemented a CRO improvement initiative through the revision of the ICF and Protocol Deviation Management process to streamline clinical trial operations, leverage CRO expertise in trial execution, and enhance data quality
- Supported development of a new template for an integral study tracking document used across all Gilead studies.
- Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.
- Developed and implemented strategies to increase site responsivity and engagement.
Clinical Project Associate
Gilead Sciences
05.2021 - 09.2022
- Communicate with CRO about site responsibilities for EAC data entry into new EDC system, simultaneously working closely with GSI Data Management to ensure data is being correctly inputted
- Coordinate all teams to successfully perform Interim Functional Quality Control (FQC) quarterly beginning May 2021 including performing FQC of more than 300 documents quarterly
- Evaluate IMV/OIMV/PSSV/COV reports and escalate any concerning issues or trends with monitoring quality and/or site compliance.
- Enhanced team productivity by streamlining communication and implementing efficient project management tools.
- Improved reporting accuracy, implementing new data management system.
Clinical Research Coordinator
University of California, San Francisco
01.2019 - 10.2019
- Scheduling and conducting patient study visits for vascular surgery device trials including specimen collection intra-operatively and post-operatively
- Creating and modifying study specific materials including Informed Consent Form, Case Report Forms, subject recruitment materials
- Ongoing monitoring of physicians clinical and surgical schedules for potentially eligible surgical device study patients
- Daily communications with local and private IRBs regarding sponsor-initiated and investigator-initiated research studies
- Frequent types of submissions: initial study applications, protocol modifications, serious adverse events
- Formed and maintained functional, successful relationships with sponsors and CROs
- Acted as primary point of contact for in-depth, multi-day on site monitoring visits
- Write interim and annual report of research subject data, including usage of Stata for graphical representation of endpoint frequency and survival analysis
- Ordering and maintaining operating room inventory of commercial and investigative thoracoaortic branching devices.
Assistant Clinical Research Coordinator
University of California, Los Angeles
08.2017 - 11.2018
- Prepare patient visit kits for all subjects in Hematology-Oncology clinical trials
- Maintain constant supply of adequate and current materials for more than 20 active studies at any given time including updating on-site laboratory manuals and protocols
- Develop and maintain a functional and symbiotic relationship with site monitors representing pharmaceutical sponsors during site activation, study monitoring, and study close visits
- Coordinate collection, retrieval and processing of upwards of 20 blood and bone marrow specimens for each trial patient per day
- Personally packaged and shipped upwards of 50 PD, PK, bone marrow aspirate specimens to various central (Covance, ICON, Janssen, etc) laboratories weekly
- Resolve discrepancies raised by financial administration and billing by appropriately directing charges as dictated per sponsor-UCLA contract agreement.
Laboratory Technician
University of Southern California
08.2016 - 08.2017
- Receive and accession all histological specimen collected from USC Norris Cancer Center and Keck Hospital daily
- Receive and accession all externally collected histologically samples sent to USC’s dermatopathology department for review.
Laboratory Technician
Bloodworks Northwest
02.2014 - 08.2016
- Receive and accession patient samples for specific immunogenetic testing routed from all major hospitals in Seattle including Harborview, Virginia Mason, Swedish, and the University of Washington.
Blood Collection Specialist
Bloodworks Northwest
- Register, screen, and perform venipuncture in the antecubital region for donors and patients to collect either whole blood or apheresis products.
Education
Bachelor of Science - Biology
University of Washington
Seattle, WA01.2013
Skills
- Extensive experience in a multitude of EDC systems ranging from REDcap to Veeva
- Participant in multiple successful FDA audits at various organizations
- Highly skilled in all Microsoft Office programs
- Robust track record of specimen procurement, packaging, accessioning, retrieval, query resolution
- Phlebotomy expertise
- Good Clinical Practices
Activities
- Reduced the number of outstanding RECIST images from over 100 to 0 between September 2022 and March 2024 using risk analysis and proactive modification of collection process
- Successfully completed 3 study-wide database locks between April 2023 and March 2024, ensuring all projected filing timelines were maintained
Accomplishments
- Led the Bloodworks NW Diversity and Inclusion "Pride" committee, leading the organiziation's first Pride march in 2016
- Won the Bloodworks NW "Outstanding Acheivement" award for piloting a new blood collection program
Timeline
Clinical Trials Management Associate
Gilead Sciences
09.2022 - 04.2024
Clinical Project Associate
Gilead Sciences
05.2021 - 09.2022
Clinical Research Coordinator
University of California, San Francisco
01.2019 - 10.2019
Assistant Clinical Research Coordinator
University of California, Los Angeles
08.2017 - 11.2018
Laboratory Technician
University of Southern California
08.2016 - 08.2017
Laboratory Technician
Bloodworks Northwest
02.2014 - 08.2016
Blood Collection Specialist
Bloodworks Northwest
Bachelor of Science - Biology
University of Washington
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