I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way of preparing and treating documents for each study. I would someday love to become a project manager, and I feel that every job that I have had is preparing me closer and closer everyday for such a role. I shadow and watch closely the way the study manager manages and delegates study responsibilities. I am very observant and always willing to jump right in and do what needs to be done to keep the study rolling smoothly. I have ample experience working side by side physicians and feel very comfortable doing so and have a high confidence level in managing studies and being flexible in priorities and timelines as the Sponsor requires. I use lists everyday, and follow them until all of my tasks are checked off and before leaving for home, I will make a list of tasks that I will need to do when I arrive immediately the following day. I am also bilingual in Spanish and of course English. This has helped me tremendously here in southern California where the Spanish speaking population is high. So I have experience in foreign studies and the legal requirements that need to be followed. There is not much I have not seen in managing clinical research. I feel confident in my abilities and work great with others.

SCHOOL	MAJOR	YEAR	DEGREE
Brigham Young University-Hawaii	Post Bachelorette Studies	2010	Some College Units Completed Degree
Brigham Young University-Hawaii	International Business Management	2007	Bachelor Degree

TYPE	TITLE	URL	DESCRIPTION
Book	Business Process and Developement	media url	Books from Malcom Gladwell on business case studies and learning from reactions to situations from customers to help streamline processes and develop new ways of dealing with customers.

Highlights:

There are a lot of trials that I have been apart of that have gone on to the approval phase and found out that through the Data Management Safety Board that the data looks great and that the trial was awarded enough money to continue its recruitment and dosing until we see actual physical evidence that the patient is improving. Also using Compassionate Use with our study drug to help save a little 5 year old's life as this was the only remaining treatment available that might work and save the boys life. It worked, and this not only gave validation to this drug, it gave valuable data and prove that this can save lives of children with pneumonia. It was quite a special moment within our study team.

Companies I like:

Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies

Marketing for subject recruitment
patient care and making sure patients are treated with great care and upmost respect and with a smile
Critical thinking under fast paced work enviornment
Ability to quickly assess a situation and prioritize its importance
Able to multitask across various studies and keep studies organized seperately
Have the capacity to know where in what process a study is currently in and what upcoming needs is possesses
able to work by myself as well as in a team setting
Can take on a study and complete every task from subject recruitment, study visits including phlebotomy, ECGs, Vitals, Lab Processing and Shipping, Sponsor Visits, Monitor Visits, Study Audits, TMF Maintenance, Study Close Out Procedures.
Can work with Doctors and Pharmacists and have a working relationship with all upper management. I am easy going and easy to get along with.
Able to spot issues and report them to the appropriate department in a quick time frame.
Ability to spot issues in procedures and streamline them into a more user friendly and efficient way
I pay high attention to quality and detail. I ready over things twice in case I missed anything the first time around.
Not afraid to speak up in a meeting about some issue or some process that needs attention. I have a high confidence level in my decision making skills.
Have perspective from Phase 1 clinics, Sponsor level, and CRO level of work. This helps in problem solving and streamlining processes since I have "been there and seen that" type of work. A well rounded experience would sum it up.
Can build a Trial Master File from the ground up. From Site Level to Core Level documents and know what it needed and where specific documents should be found.
Can assess a subject and know when something is not right and what questions I should ask to help recognize an Adverse Event.
Know the importance of HIPAA regulations and follow them regardless of the situation.
Follow GCP/ICH guidelines and know them very well.
I leave personal issues at the door and focus only on work during the day.
Very professional in communication and always am in communication with my study team and anyone that would benefit from the given information. Keeping everyone "in the loop"
Can create from scratch source documents directly from a protocol and its information in the subjects schedule of events and pay close attention to procedures and the minutia involved.
Can take PK and PD data from Clinical Study Reports and provide Doctors with graphs to show differences in PK levels in multigenerational studies.
Can delegate tasks and can lead a team in a project from beginning until completion with little to no supervision.
Not afraid to take on new tasks and assignments out of my comfort zone. This is where I learn and grow in my skill set.

• Instant Messaging
• Data Analysis
• Document Management
• Good Clinical Practices
• Good Laboratory Practices
• Management
• Medical
• Medical Terminology
• Microsoft
• Microsoft Excel
• Data Entry
• Site Feasibility
• Trial Master File Audit
• Trial Master File
• Routine Monitoring Visits
• Bilingual
• IWRS Systems
• DSMB
• analysis of PK data from different generations of Japanese subjects
• Receiving Plasma samples and storing them in freezers
• Urine collection and UA testing
• Phlobotemy
• ECGs
• Dosing
• Writing Visit Reports
• Query data sheets
• Resolving Queries within the SOP allotted time frame
• Pippetting Fluids and shipping off with appropriate courier.
• CRA visit matrixes
• Reporting numbers and statistics to Project Manager and Operations Manager
• Reviewing Source Documents and making original source documents according to procedures in the protocol
• Protocol review sessions
• QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed
• Call subjects and perform AE checks according to timelines on protocol
• Send critical documents to sites directly or through CRAs as demanded.
• Make progress matrices of site visits and site reports
• Send reminder emails for upcoming visits for CRAs and internal deliverables
• Coder

Making sure Study Drug is in the hands of the clinic workers who are doing the dosing on subjects. Making sure the IWRS matches and that the correct drug is given to the correct subject at the correct time. I also oversee timelines that I make for the traveling CRA's in the field for their schedules in conducting the appropriate visits whether it is the Site Feasibility Visit, Site Initiation Visit, Routine Monitoring Visits, or a Study Close-Out Visit. I am also flexible when issues at sites come up. I try to for see problems before they actually occur and that might be the reason there are more visit 3 study kits for example due to the fact that it requires an exact amount of blood for example and these extra kits give us that wiggle room to perform the visit on time and without delay. I am also in constant contact with my study team. Since I have managed and seen many studies I like to keep close communication to the team when potential trouble spots may hit during the study, this helps the CRA's have a heads up view of their upcoming week and potential issues they may see and not be surprised by them.