Diana Araya Monge

**** ** ***** ******* ******** 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

WORK EXPERIENCE

Providence Health and Services March 2020 – Present Providence Cancer Institute

• Regulatory Affairs Specialist

• Device Regulatory submission process

• Noridian FUP

• IRB new study submission and maintenance

Monser Asesorías Clinicas, Clinical Research Organization

(this company is a Latin America vendor of worldwide CROs ) ACRP Member since 2008

Senior Clinical Project Manager Remote and travel to Latin America From San Francisco, CA and Portland OR 2016-March 2020

• Feasibilities and Budget Negotiations

• Negotiation of new hires and contracts

• Site Staff and CRA recruitment

• Delegation duties and responsibilities

• Human Resource calculation for Clinical Trial

Development

• Timelines follow up

• Deadlines and timelines follow-up

• Validation of Monitoring Reports

• Payroll Support and Expends reports support

• Monitoring Visits travel arrangements

• Executive relocation efforts in other countries

• Designed and implemented Standard Operating

System manual.

• New Markets development

Senior Clinical Research Associate From San Jose, Costa Rica 2010- 2016 Cover Latin America and support USA

• Roof Case Analysis Activities and Implementation of Corrective and preventive action plans ( CAPAs)

• Monser S.A. Trainer of GCPs, Clinical Trials

procedures for Principal Investigators, Clinical

Coordinators and new Clinical Research Associatte.

• Site Preparation for FDA Audit

• Regulatory Quality

• Initiation Package specialist and start up of Clinical Trials Projects

• Safety Data Base procedure and authorities reports Personal Skills and Abilities

Ability to make decisions Curiosity Friendly personality Ability to resolve problems Effective communication skills Good education Attention to the details Energetic manner Reliability and Empathy Creativity Flexibility Technical Knowledge

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

Special Projects with Monser Clients

Organization of Corporate Events like Conferences, Investigator meetings, retention plans for Patients, Anniversaries of Clinical Trials Institutions.

Pfizer Institute program for sponsor Clinical Trials or Principal Investigator statistical projects

Device Development, with Mayo Clinic, Tenex health product. Project Manager for Protocol development.

GSK Vaccine Project Coordinator of 23 Clinical Research Associate, and re-monitoring 5000 patients files, Panama

Establishment of political relations with the regulatory authorities of Latin America for the legislation of clinical studies in the region, Collaborate with Costa Rica new law design and implementation

Pfizer Remote Regulatory documents and audit analysis for Asia, Europe and United States

Baxter Health Care Audit of Image and lobby for new plant construction plans in Costa Rica. Pfizer San Jose, Costa Rica 2007-2010

1-Senior CRA

• Coordinator of Clinical Trials, and development of new projects, submission package timelines

supervision, coordinator of Low volume countries

reporting to London, England

• Clinical Trial Project Manager for developments

projects in Mexico- Central America and Caribbean

• Local SOP development.

• Quality and CAPAs Senior Coordinator

• Budget and Feasibilities.

• Site selection and PI validation

• Submission Package Coordinator and Start up

• Site Initiation visit, Monitoring Visit and Close up Visit Activities

• Monitoring Visit Plan

• ELARA and Regulatory documents validation

2-Central America Depot Coordinator of Drug Supply 2005-2007

• Drug Supply Accountability

• Drug Costume Release Support

• Re-label

• Dispatch from Clinical Pharmacy to the Patients

• Prescription Preparation

• HIPAA Compliance

• Storage and temperature Log

• Return Drug accountability

• Compliance validation

3-Clinical Coordinator and CTA 2002-2005

• Scan and Classify Regulatory Documents

• Complete Logs with the source documents

Information

• Submission Package

• CRAs Support and ICF log

• Blinded Activities

• Training Clinical Coordinator activities

4- Public Affairs

• Advocacy patients programs for participation in clinical trials

• “Chao Lombriz” Campaign of deworming application program 2000-2002 Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

INTEL (ASINTEL), San Jose, Costa Rica 02/1998-2000 Administrative team (Green badge)

• Provided guidance to the corporation in order to attract employees to be part of the employees

Association.

• Verified that we achieved almost the 100% of

the new employees joining the Solidarity

Association of employees.

• New Employee Orientation organization support

• Responsible for Stretching Activities, and

Internal communications Campaigns

• Organized Supplies and Vendors

• Organized sports and health fairs for employees

• Developed a sale of expatriate household goods

donated by the company to employees

• Safety First campaign Certification in sprung

Building and CR3

• Relationships of trust with the local government

• Expense Report Support and travel Support for

the Manager

• Supplies distribution and logs

• Relocation Support Activities

• Relationships with schools and universities • Planning student visits to the production plant. Education:

• B.S. Science Communication with Emphasis in Public Relations in Public Relations 02/1994 – 05/1997 Universidad Latina - San Jose, Costa Rica

• Clinical Research Associate Certification

• Pfizer University CRA internal Program 02/2002-09/2008

• ACRP member USA Since 2008

Seminars

• Protocol, Etiquette and Special Events Universidad Latina de Costa Rica

• Life Science Forum CINDE 2016

• Seminar Silicon Valley Market development (San Mateo California College) 10/10/2017

• Portland Community College

o ESOL (level 8) since Jan 2018

o Fundamentals of Clinical Trial September 2019

o Good Clinical Practice September-2019

Oregon Pharmacy Technician certification

Oregon Board of Pharmacy

Licensed

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

REFERENCES

ERIC HEILBRON,MD

ASTRAZENECA

MEDICAL DIRECTOR

Central America, Caribbean and West Indians

adyrb0@r.postjobfree.com

phone (506-****-****

B.

TATIANA MONTERO,MD

BAYER

Medical Manager Women Healthcare

Central America and Caribbean

adyrb0@r.postjobfree.com

adyrb0@r.postjobfree.com

(506-****-****

C.

MARIANELA ROJAS

GlaxoSmithKline ( GSK )

Manager of study Delivery

adyrb0@r.postjobfree.com

phone 202-***-****

USA.

D.

VERONICA HERNANDEZ

EVRAZ

HUMAN RESOURCES

adyrb0@r.postjobfree.com

phone 971-***-****

USA.

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

Diana Araya Monge

7784 NW SITKA TERRACE PORTLAND 97229

adyrb0@r.postjobfree.com 503-***-**** / 503-***-**** Spanish- English

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