Jeremy Fernandez has over 10 years of experience in clinical research and data analysis. He currently works as a Regional Manager and Data Scientist for the Colorado Cancer Research Program, where he performs data analysis on large datasets, identifies trends, and presents findings. Previously he has held positions as a Clinical Research Associate, Data Coordinator, and Clinical Trials Coordinator for various studies. He has extensive experience ensuring regulatory compliance and has developed training programs and standard operating procedures.
1. Jeremy Fernandez
473 Oxbow Dr., Brighton, CO 80601; Ph: 720-339-3336; E-Mail: JeremyFernandez@comcast.net
Career Summary: Working in challenging positions, applying my database skills and research knowledge to present data
in an understandable/useful manner.
Education: University of Colorado at Denver – Bachelors of Science; Major: Biology
Skills:
Data Mining, manipulation and analysis
Ability to qualitatively and quantitatively present large sets of data in a meaningful manner
Proficient in Microsoft Office
General Laboratory processes (chemistry and biology) including specimen processing
Microscopy image analysis and microscopic techniques
Project Management
Employment: Colorado Cancer Research Program, 1720 S. Bellaire St., Suite 701, Denver, CO 80222 (July 2009 – Present)
Regional Manager (Sr. Clinical Research Associate) /Data Scientist– February 2014 – Present: Directly report to senior
management and the CEO/President. This position performs data analysis on large data sets pulled from the
organizations database. Identifies issues and creates metrics from the data. Create graphs, perform statistical analysis
and present trends from the large data sets as well as complete analyses for predictions of future trends at the
organizational and single hospital levels. Develop and implement processes to create metrics from the database by
writing and implementing standard operating procedures. Update SOPs as issues are identified or review every two
years if nothing has changed to the processes. Input/creation of pre-outlined schedules from sponsor protocols into the
database for staff use and maintenance of the database schedules and processes. Oversee two direct reports that aide
in the creation and maintenance of the database schedules. Perform one on one training and new hire orientations on
database usage as well as complete presentations twice a year on the database and its use. Track query input and data
management using the database to create metrics and trends. Maintain company website by posting, designing and
manipulation of website pages using Microsoft Expression Web 4. Help the CFO to track financial clinical events using
the database and performing double checks against the protocol and actual participant visits to ensure accuracy.
Oversight of organizational drug accountability/administration and laboratory processes for 21 affiliate hospitals
throughout Colorado and Southern Wyoming. Ensure all 21 affiliates adhere to GCP and CFR21 parts: 11, 50, 56, 209,
310 & 312 as well as any FDA and NCI regulations. Wrote and maintain a technical manual on how to properly complete
drug accountability record forms for the Colorado Cancer Research Program. Implement/maintain SOPs developed from
issues found or requests from sponsors. Perform new hire orientations on drug accountability and laboratory processes.
Complete continuous monitoring of drug accountability/administration and laboratory processes of over 70 protocols to
ensure compliance and patient safety. Present bi-annually at company conferences on drug
accountability/administration. Perform protocol feasibility to determine the logistics of performing clinical trial activities.
Prepare the organization for sponsor/NCI audits. Also control the blind in blinded studies and when required be the
unblended person and prepare the dose for another CRA.
Clinical Research Associate – July 2010 – February 2014: Complete protocol activities according to GCP and the code of
federal regulations as it pertains to research. Consented and performed clinical visits with study participants. Completed
data in accordance to sponsor requirements and answered queries as needed. Aided in the development of
documentation tools and forms for the organization, to better document clinical trial visits as outlined by each protocol
and sponsor. Involved with over 70 clinical trials and performed clinical trial activities as outlined in the protocols.
Oversight of drug accountability and laboratory processes. Responsible for the maintenance the medical database for
the organization, by building database schedules according to protocol specifications. Performed new hire orientations
and presented at bi-annual company conferences. Performed monthly organizational webinars/trainings the
organization/staff how to better utilize the clinical trial database.
2. Data Coordinator – January 2010 – July 2010; January 2013 – June 2013: In 2010, worked as a contract employee to
bring data for Exempla Lutheran’s research department up to date. There were many years of outstanding case report
forms that needed to be submitted as well as several outstanding queries. In the six months working for this facility the
data went from being delinquent to being current and the outstanding queries were answered. In addition to learning
the data coordinator position, I cleaned up the database for this affiliate by inputting years of information to bring them
up to a manageable point to use the database. Working many hours and researching several records in order to answer
several year old queries as well as delinquent data collection forms. Processed specimen collection for a large subject
load as well as adhering to hospital policies and procedures.
In 2013 as a permanent employee of the Colorado Cancer Research program another affiliate site was identified as
having many years’ worth of delinquent data and outstanding queries. I successfully submitted the delinquent data and
answered the queries/data clarification forms. It was identified that the data needed to be completed at the main office
as the site was understaffed to complete the data and see the patients.
Starting in July of 2010 I started providing oversight of drug accountability and laboratory processes. I identified the
need for more stringent monitoring and wrote a technical manual on how to perform correct drug accountability
according to NCI standards as well as taking on the responsibility of maintaining the medical database for the
organization, by building database schedules according to protocol specifications. I created new hire orientation packets
and started to create trainings for the organizational staff on how to properly perform drug accountability that was
presented at bi-annual company conferences.
Clinical Trials Coordinator for the SELECT study – July 2009 – March 2011: Performed clinical trial visits and kept track of
over 55 study participants for the Denver, Boulder and Longmont areas. This required monitoring of participants health
and concomitant medications to be reported on case report forms and submitted to the sponsor. It was necessary to
collect correlative science specimens within specific timelines and properly ship the specimens to the research base for
future analysis.
The study sponsor decided to move all patients, who were all in long term follow up, to a central monitoring program.
All participants needed to be consented/re-consented to take part in the centralized follow up. The consent and
registration to the centralized follow up allowed for the collection of cancer control credits from the NCI that was crucial
to the survival of our organization.
Once all the participants that wanted to participate were identified and transferred a site study closure procedure
needed to be implemented. This was done in accordance to all regulations and marked for storage. and consent to a
centralized long term follow-up program
Total Car Care, 348 Bridge Street, Brighton, CO 80601 (November 2008 – January 2010)
Internet Administrator/Shop Hand – As the internet Administrator I was responsible for taking pictures of cars for sale to
post to the website as well as posting the vehicles to other websites for advertisement. As a shop hand, I completed oil
and brake services as well as repaired auction cars for sale on the car sales lot. This required auto body and paint work.
The Home Depot, 16420 Washington St., Thornton, CO 80023 (May 2007 – May 2008)
Lumber and Building Materials Associate – Maintained the departments by using forklift equipment to stock lumber and
other large items shipped on pallets. Helped customers select the proper materials for the construction of decks, play
grounds and concrete structures. Filled customer orders for delivery and helped load materials into customer trailers
and trucks. Obtained several employee of the month awards.
ACT, Inc., 3131 S. Vaughn Way, # 218, Aurora, CO 80014 (July 2005 – December 2006)
Work-study/Office Assistant – Obtained the position through the work-study program for financial assistance through
the University of Colorado at Denver. After a few semesters, I was hired on as an office assistant. I completed many
projects for conferences, updated financial records, and input conference feedback into a spreadsheet for the
presenters.