Mary Arce
Portland,OR
Summary
Dependable Clinical Research professional with 25 years of experience. Resourceful problem solver with proven ability to bring quick resolution to challenging situations. A team-oriented professional who works well under pressure, is goal oriented, with a commitment to exacting research. Extensive experience with regulatory compliance, Good Clinical Practice and ICH guidelines. Through attention to detail and high standard of accuracy, and integrity. Areas of therapeutic experience include: Neuroscience, Endocrine, Cardiac Device, HIV, Dermatology, Metabolic Syndrome, Oncology, Gastroenterology, Cardiology, Vaccines, Rheumatoid Arthritis, Osteoarthritis, Pain Management, RSV, and Ophthalmology.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Senior Site Manager
Janssen
11.2019 - Current
- Perform on-site and remote monitoring visits with emphasis on Site Selection and Site Initiation
- Mentor and assist with onboarding of junior Site Managers.
- Assist sites prior and during Site Initiation with an emphasis on predictable and quick site activation.
- Collaborate with Clinical Trial Assistants during study start up to ensure the site budget/contract is executed quickly and smoothly.
- Assist with Local Trial Managers and Clinical Trial Assistants with ongoing maintenance of the Virtual Trial Master File (VTMF).
- Manage sites to resolve all site related issues on an ongoing basis.
- Review and approve study source documents for assigned sites.
Senior CRA
IQVIA
05.2015 - 11.2019
- Monitor phase II-IV studies in the areas of CNS, Endocrine, Rheumatology and Dermatology
- Perform on-site and remote monitoring visits
- Manage sites to resolve all site related issues on an ongoing basis
- Review and approve study source documents for assigned sites
- Assist sites with initial regulatory document collection and submission
- Assist in the onboarding and mentoring of junior CRAs.
Senior CRA
inVentiv Health Clinical
09.2013 - 02.2015
- Monitor phase II-IV studies in the area of Dermatology Cardiology and Urology.
- Conducted pre-study site selection visits to evaluate adequacy of site, investigator, and research staff.
- Conducted all types of site visits.
- Managed sites to resolve all site related issues on an ongoing basis.
- Performed essential document site file reconciliation.
Senior CRA
PRA International
01.2013 - 08.2013
- Monitor phase II-IV studies in the area of CNS.
- Conducted pre-study site selection visits to evaluate adequacy of site, investigator, and research staff.
- Managed sites to resolve all site related issues on an ongoing basis.
- Completed monitoring activity documents as required by PRA SOPs or contractual obligations.
- Worked closely with other clinical team members to facilitate timely resolution of trial and or clinical issues.
Senior CRA
Quintiles Transnational
09.2008 - 01.2013
- Monitor phase II-IV studies in the areas of Endocrine, Neuroscience and Urology.
- Provided on-site orientation to Investigators and other site personnel.
- Conducted ongoing monitoring visits to assigned investigational sites.
- Prepared and submitted timely appropriate monitoring forms and site visit reports.
- Participated in Project Team meetings.
Phase I Clinical Study Manager
Covance CRO
Portland, OR
06.2007 - 09.2008
- Responsible for the daily activities involved in clinical trials; managed the direction, planning and implementation of clinical research trials.
- Key team member for proper study execution, which included recruitment and enrollment strategies, oversight of study conduct, compliance with regulatory standards and completion of data entry.
- Served as the primary point of contact to the sponsor regarding issues related to trial conduct.
Clinical Research Coordinator
The Portland Clinic, LLP
Portland, OR
03.2003 - 06.2007
- Coordinated clinical research trials in the areas of: Hypertension, Women’s Health, Dermatology, Depression, Smoking Cessation, Prostate Cancer, and Metabolic Syndrome.
Clinical Research Coordinator/Team Leader
Americas Doctor CRO
Portland, OR
02.1999 - 03.2003
- Coordinated clinical research trials in the areas of: Gastroenterology, Cardiology, Endocrinology, and Women’s Health
- Team Leader to five Clinical Research Coordinators, and two Research Assistants.
Education
Bachelor of Science - Health Care Administration
Concordia University
01.2008
Skills
- Excellent communication, both written and verbal
- The ability to build effective relationships with trial center staff and colleagues
- Excellent writing skills with attention to detail
- Experience in all phases of clinical trials
- Excellent organization and problem-solving skills
- Ability to work on multiple trials simultaneously and mange conflicting priorities
Certification
Society of Clinical Research Associates, Certified Clinical Research Professional (CCRP)
Timeline
Senior Site Manager
Janssen
11.2019 - Current
Senior CRA
IQVIA
05.2015 - 11.2019
Senior CRA
inVentiv Health Clinical
09.2013 - 02.2015
Senior CRA
PRA International
01.2013 - 08.2013
Senior CRA
Quintiles Transnational
09.2008 - 01.2013
Phase I Clinical Study Manager
Covance CRO
06.2007 - 09.2008
Clinical Research Coordinator
The Portland Clinic, LLP
03.2003 - 06.2007
Clinical Research Coordinator/Team Leader
Americas Doctor CRO
02.1999 - 03.2003
Bachelor of Science - Health Care Administration
Concordia University
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