Wendy Engelbrecht, CCRA
Seattle,WA
Summary
- 19 years clinical research experience, 10 years leading clinical teams (up to 11 CRAs), 7 years on-site monitoring experience
- Phases I - IV
- Global clinical team lead experience
- Demonstrated success in leading CRA teams to consistently meet or exceed study milestones
Overview
22
22
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Associate
Worldwide Clinical Trials
10.2019 - 07.2020
- Launching Neurocrine study – got to first SIV successfully, more site were added than originally discussed
- Talk about how many databases were closed out (on time)
- Met every data deadline while at company
- Developed new process for reg doc checklist/CRA review
- Facilitated transition to Veeva Vault mid-study
- Did a bid defense and won the study
- Responsible for ensuring appropriate resources, coordinating and managing the clinical operations team and providing operational leadership and expertise to ensure successful execution of the clinical operations deliverables (quality, timeline, budget, and scope)
- Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters
- Manage the design, implementation, and revision of the clinical monitoring plans and clinical operation training plans for assigned projects
- Develop risk contingency plans for key clinical operations activities in collaboration with the project manager
- Responsible for issue escalation, corrective and preventative action plans (CAPA), and corrective action issue resolution related to clinical operations deliverables
- Own the development of training material and tools (project-specific and site monitoring) as well as training specific to the clinical operations team
- Ensure timely filing, proper archiving of all clinical operations sections of the Trial Master File (eTMF)
- Contribute to the operational plan and participate in the delivery of bid defense presentations for new business
Clinical Team Lead
Covance, Inc.
09.2015 - 03.2019
- Served as Lead CRA for Phase4 trial launch for CRA start-up team:
- Led budget/contract negotiation and start-up document receipt/review
- Communicated site start-up status and study metrics in client meetings
- Served as Lead CRA on all assigned studies: CRA training and co-monitoring; monitoring report review
- Independently conducted on-site initiation and interim monitoring visits for Phase1/2/4 studies
Senior Clinical Research Associate
TFS HealthScience
09.2013 - 12.2014
- Served as Lead CRA for Phase4 trial launch for CRA start-up team:
- Led budget/contract negotiation and start-up document receipt/review
- Communicated site start-up status and study metrics in client meetings
- Served as Lead CRA on all assigned studies: CRA training and co-monitoring; monitoring report review
- Independently conducted on-site initiation and interim monitoring visits for Phase1/2/4 studies
Clinical Trial Manager
Dendreon Corporation
07.2011 - 06.2012
- Independently managed two Phase2 studies
- Managed launch of company’s first bladder cancer study: timeline/milestone development, budget/resource management, staff training, vendor selection/management, study metric tracking, and cross-departmental collaboration to meet milestones
Senior Clinical Research Associate I/II
Dendreon Corporation
07.2008 - 07.2011
- Independently conducted on-site qualification, initiation, interim, and close-out visits for Phase2/3 studies
- Mentored and trained CRAs through co-monitoring
- Assisted in managing two Phase2 studies: led inter-departmental team meetings, contributed to protocol and CRF development, tracked metrics and resolved barriers to study goals, monitoring report review, vendor management, served as primary liaison for site contract/budget negotiations and tracking
Clinical Research Associate I/II
Dendreon Corporation
01.2006 - 07.2008
- Independently conducted on-site interim and close-out visits for Phase2/3 studies
- Served as Lead CRA for Phase2 study:
- Tracked regulatory documents study-wide and ensured timely resolution of start-up action items
- Assisted in selecting and managing two central lab vendors
- Authored Monitoring Guidelines, ICF templates, CRF Conventions, and study reference materials
- Contributed to protocol and CRF development
- Tracked enrollment and key study metrics
Clinical Trial Associate (CTA)
Dendreon Corporation
11.2004 - 01.2006
- Managed central IRB submissions
- Conducted in-house site master file audits for CTMS database reconciliation
- Managed protocol endpoint documentation and independent radiology review
- Assisted in selecting qualified investigators and negotiating site contracts/budgets
Clinical Research Coordinator/Assistant CRC
Summit Research Network
01.1999 - 11.2004
- Led a cross-functional team to enroll200 participants in a smoking cessation study
- Managed start-up, operation, and close-out of multiple Phase2/3 studies
- Acted as liaison between site and sponsors, IRBs, and central labs
- Conducted study visits, managed IP accountability, maintained source documents, and completed CRFs
Education
B.A. - Psychology, Magna Cum Laude
Whitworth University
Spokane, WASkills
- Microsoft: Word, Excel, Outlook, PowerPoint, SharePoint, Teams, Project
- Clinical trial management systems (CTMS)
- Electronic data capture (EDC) systems, including Medidata RAVE and Oracle Clinical
- ETMF systems, including Veeva Vault
- Electronic Diaries (eDiaries)
- Adobe Reader/Writer
Therapeutic Experience
- CNS: Dementia, Generalized anxiety disorder (GAD), Major depressive disorder (MDD), Premenstrual dysphoric disorder (PMDD), Smoking cessation, Social anxiety disorder
- Oncology: Advanced solid tumors, Cervical neoplasia, Metastatic melanoma, Non-small-cell lung cancer (NSCLC), Ovarian cancer, Pancreatic cancer, Prostatic adenocarcinoma/Prostate cancer, Urothelial carcinoma/Bladder cancer
- Rare Disease: Congenital adrenal hyperplasia (CAH)
- Respiratory: Asthma, Chronic obstructive pulmonary disease (COPD)
- Urology: Peyronie’s disease
Certification
- Certified Clinical Research Associate (CCRA), ACRP,2008 - Present
- Certified Clinical Research Coordinator (CCRC), ACRP,2002 -2004
Timeline
Lead Clinical Research Associate
Worldwide Clinical Trials
10.2019 - 07.2020
Clinical Team Lead
Covance, Inc.
09.2015 - 03.2019
Senior Clinical Research Associate
TFS HealthScience
09.2013 - 12.2014
Clinical Trial Manager
Dendreon Corporation
07.2011 - 06.2012
Senior Clinical Research Associate I/II
Dendreon Corporation
07.2008 - 07.2011
Clinical Research Associate I/II
Dendreon Corporation
01.2006 - 07.2008
Clinical Trial Associate (CTA)
Dendreon Corporation
11.2004 - 01.2006
Clinical Research Coordinator/Assistant CRC
Summit Research Network
01.1999 - 11.2004
B.A. - Psychology, Magna Cum Laude
Whitworth University
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