1. Christopher Brawley
1017 W. Hamilton Ave. Apt. 2 Campbell CA 95008
T 408 930-9475
cbrawley@gmail.com
EXPERIENCE
Clinical Trial Manager, Natera Inc.
San Carlos, CA- June 2016 – Present
Responsible for the implementation of large volume clinical trials activities per study protocol.
Works closely with investigative sitepersonnel, CROs, and other study vendors to ensure protocolexecution
Managed study contracting, budget and payment process for all clinical trial vendors including investigational sites
Designed study related documents and templates, including but not limited to study protocol, informed consent forms,
CRFs, and regulatory binders
Responsible for siteselection and initiation
Trained CROs, vendors, investigators and study coordinators on study protocoland relevant requirements
Monitor and track clinical trial progress and provide status updateto stakeholders, through the creation of study
progress dashboards, and other tracking metrics
Created Clinical Study Report templatefor Natera, Inc
Senior Clinical Trial Management Associate Hematology/Oncology, Gilead Sciences;
Foster City, CA- February 2016- June 2016
Assisted in the development and planning of investigator meeting agenda and content.
Developed materials and training slides for use at investigator meeting
Presented protocolspecific training at investigator meeting for both general and breakout sessions
Created dashboard metric slides to provide transparency amongst both internal and external members of our study
team.
Assisted in the development and updating of study timelines
Participated in departmentalor interdepartmental strategic initiatives under general supervision
Participated and effectively ran meetings and conference calls with CROs, vendors, and multi-functional teams
Developed new study specific training materials for use at both thesite and CRO level
Anticipateobstacles and proactively develop solutions to achieve project goals
Interfaced with individuals in other functional areas to address routine study issues through study management team
meetings
Assisted in the training of CTMAs and CPAs
Reviewed of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Clinical Trial Management Associate Hematology/Oncology, Gilead Sciences;
Foster City, CA- August 2014 –February 2016
Developed a cross functional process, using an existing internal database, to automate appendices required from
Clinical Operations for thefinal CSR (awarded 2015 innovation award for clinical operations)
Independently managed study vendors and scope of work changes for two global hematology/oncology phase2 clinical
trials
Documented and escalated serious vendor issues affecting our study to share with our company as a whole to prevent
future occurrences.
Led cross functional development and execution of protocolamendments, and proactively requested feedback on future
protocols in development to ensure all necessary changes were implemented
Performed monthly review of vendor budget variance reports and unprocessed site payment reports consolidating
invoices across data obtained from multiple data platforms
Developed of site facing documents to address laboratory processing issues surrounding critical central lab values for
safety analysis
Developed strategy and scenario build for UAT testing for study vendors.
Participated in and UAT testing for vendors prior to study startup.
Assisted in the development of study dataquality review plan to outline review process.
Established study specific Trial Master File plans to allow for use of a central TMF as well as an off-site CRO TMF
Performed routine TMF reviews on both central files and off-sitefiles
Assembled and delivered Clinical Operations sections for CSR publication.
Participatein routine data line listing review to support preparation of safety, interim and final study reports
Developed and delivered protocolamendment training to study vendors and clinical research organization.
2. Identified and resolved an internal systemautomated error surrounding assigned visit cost and updated protocolnaming
convention resulting in sites not receiving proper reimbursement for study visit
Authored study newsletters to address study sites on pertinent study information on an regular basis
Ensured proper escalation regarding important protocoldeviations that occur throughout the study as well as ensuring
that the appropriateactions have taken place to mitigate any future risk
Established routine CRO monitoring report reviews to address any issues surrounding monitoring trip or report quality
Performed essential regulatory document review and approvalprior to site activation
Facilitated cross functional study management team meetings, providing accurate documentation of decisions reached
and action items assigned
Recipient of May 2015 Oncology Star Award
Recipient of peer to peer G-Thanks Award for onboarding of colleagues outsidemy immediate team
Senior Clinical Research Assistant, Stanford University Department of Pediatric Hematology/Oncology;
Stanford, CA- August 2012 – July 2014
Managed approximately 50 Phase I through IV clinical trials in relapsed leukemia, AML, Hodgkin disease, Non-
Hodgkin Lymphomaand Hepatoblastoma.
Developed and manage an on-line database to improve communication surrounding research participants between
research assistants, clinicians and local research laboratories.
Liaised with numerous constituencies within Lucile Packard Children’s Hospitalin analyzing and improving order sets
for chemotherapy.
Contributed to thedesign and implementation of a Division-wide policy for patients receiving investigational agents
while on a research protocol.
Developed disease-specific and consent process flowcharts to serve as reference guides for research assistants and
clinicians.
Contributed to thedevelopment and validation sessions of the EPIC medical record database implementation for
LPCH.
Assisted in the annual training of new clinical Fellows.
Oversaw training and on-boarding for newly hired research assistants and evaluate areas to improve our training
process for new employees
Assisted in the identification and resolution of performance and interpersonal issues among our team.
Monitored and reported any instances of non-compliance with Stanford, stateor federal policies surrounding clinical
research amongst junior staff.
Coached junior staff in resolving any issues surrounding the execution of their individual studies.
Facilitated CRA group discussions in evaluation of potentialCRA candidates throughout interview process.
Analyzed technical and communication skills of all CRA candidates, and provide recommendations for hiring.
Clinical Research Assistant, Stanford University department of Pediatric Hematology/Oncology; Stanford,
CA- July 2011 – August 2012
Coordinated Phase I through IV clinical trials in pediatric oncology.
Contributed in thepre-audit preparation of research material and audit process of our successful 2012 Children’s
Oncology Group audit.
Organized and implemented routine internal audits of eligibility and data quality.
Analyzed internal audit findings to recommend improvements in our internal processes.
Designed, and managed, internal database to supervise group progress for quarterly data deadlines.
Developed and coordinated an internal process to execute the ATHN hematological database.
Contributed to routine DataSafety Monitoring Committee audits of research protocols within the Cancer Center.
Prepared for, and participated in site selection visits, siteinitiation visits, routine sponsor monitoring visits, and study
close out visits.
Clinical ResearchCoordinator, UCSF Multiple Sclerosis Center; San Francisco, CA — July 2010-
July 2011
Coordinated and implemented the sound research of phasethree clinical trials specializing in the treatment of Multiple
Sclerosis.
Oversaw scheduling of on and off-site study procedures for upwards of thirty study participants.
Managed multiple clinical trials from various sponsors and ensure the sound conduct of all research procedures.
Prepared for and scheduled monthly sponsored monitoring visits.
3. Maintained numerous aspects of phasethree trials including: investigational drug storage and management, proper
storage and maintenance of study participant data, and tracking study participant compliancewithin protocol
guidelines.
EDUCATION
University Of Illinois at Urbana Champaign, BS Molecular Biology, 2007
Awards and Recognition
Recipient of the 2015 Gilead Clinical Operation Innovation Award for the automation of clinical operations
deliverables for Clinical Study Reports.
Recipient of May 2015 Oncology Star Award
Recipient of peer to peer G-Thanks Award for onboarding colleague outside of my immediate team
Recipient of Values at Work Award 2015
SKILLS
Database creation and design using the Redcap systemfor clinical research
Creating visual reference sheets that help to simplify more complex processes within clinical research
Proficient in medical terminology (including oncology)
Proficiency in Microsoft office suite
Maintaining HIPPA regulatory documents
Laboratory maintenance and inventory
Research specimen management
Obtaining informed consent from study patients
Trial drug dispensation, accountability, storage
CERTIFICATIONS
Data management for clinical researcher statement of accomplishment (Vanderbilt University)
Principles of Good Clinical Research certificate of completion
Oncology Research Forum certificate of completion
CITI Certification
BSL Level 2
REFERENCES
Available upon request