Contract Senior Clinical Research Associate - P95 - Leuven, Belgium
(2025-02 - 2026-06)
- Drove study start-up, quality oversight, inspection-readiness documentation, CRA coordination, sponsor audit support, and acting project-management coverage for decentralized and observational studies, including operational guides, study plans, tracking tools, monitoring-documentation review, site engagement, and stakeholder communication.
Contract Senior Clinical Research Associate - Tailored Clinical Research Solutions - London, UK
(2024-11 - 2025-07)
- Conducted site initiation, monitoring, and closeout visits, including staff training, file review, device reconciliation, issue follow-up, and required visit documentation.
- Reviewed on-site files, CRFs, and source documents for completeness, accuracy, consistency, and compliance; identified deficiencies and initiated corrective action as required.
- Participated in site, study, and investigator meetings and supported additional study activities as assigned.
Contract Senior Clinical Research Associate - Dedicated Site Solutions - Hellertown, PA
(2022-02 - 2025-12)
- Facilitated collection, review, and organization of relevant histopathology and imaging reports for Expert Panel review of a radiopharmaceutical imaging study.
- Coordinated with site study coordinators to obtain redacted documentation and confirmed related records in EDC for accuracy and completeness.
- Managed document uploads, meeting worksheets, signed minutes, and TMF filing to support traceability and inspection-ready documentation.
Contract Senior Clinical Research Associate - Cepheid - Sunnyvale, CA
(2022-05 - 2023-02)
- Provided short-term site coverage for four sites in an ongoing IVD GI Panel pre-clinical trial, assuming responsibilities during staffing transition.
- Conducted remote monitoring, reviewed TMF/eCRF/source documentation for completeness and compliance, and prepared monitoring visit documentation.
- Supported site management, EC submissions, regulatory notifications, study documentation, investigator recruitment, budget negotiations, IRB submissions, and final TMF audit readiness.
Contract Senior Clinical Research Associate - Linical Americas - Rockville, MD, USA
(2019-01 - 2022-07)
- Conducted site qualification, initiation, monitoring, and closeout visits, including regulatory document review, visit reporting, and study documentation.
- Reviewed site files, CRFs, and source documents for completeness, accuracy, consistency, and compliance; identified discrepancies and initiated corrective action.
- Trained site personnel, supported investigator and site meetings, and ensured follow-up actions were completed and documented within required timeframes.
Contract Senior Clinical Research Associate/ Audit Prep - CTI Biopharma - Seattle, WA, USA
(2018-05 - 2018-07)
- Reconciled global Phase III TMF documentation in preparation for regulatory inspection, including CRO-shipped trial documents, training-record matrices, training gaps, and missing essential documents.
Senior Clinical Research Associate III - IQVIA - San Diego, CA, USA
(2017-09 - 2018-01)
Senior Clinical Research Associate; Clinical Research Associate II - Covance Clinical Development Services - Princeton, NJ, USA
(2007-07 - 2017-01)
Senior Clinical Research Associate: September 2010 – January 2017 Clinical Research Associate II: July 2007 – September 2010
- Implemented project plans and managed site administration, monitoring, study-file maintenance, pre-study visits, initiation visits, closeout activities, vendor liaison, and assigned site-management responsibilities
- Clinical monitoring oversight, co-monitoring, and accompanied monitoring visits.
- CRA assessment, mentoring, and monitoring quality review.
- Monitoring Visit Report and trip report quality review and approval
- Served as Local Project Coordinator or Lead CRA as assigned, supporting feasibility, investigator recruitment, EC submissions, regulatory notifications, meetings, budgets, and agreements.
- Protected participant safety and data integrity through informed consent review, protocol compliance oversight, source document review, CRF review, query resolution, and follow-up of missing or implausible data.
- Supported SAE reporting, report/narrative production, trip reports, team mentoring, co-monitoring, and efficient monitoring execution aligned with SOPs, ICH, and GCP requirements.
Clinical Research Associate II - Pharmaceutical Products Development (PPD) - Austin, TX, USA
(2006-04 - 2007-06)
- Managed site monitoring from initiation through closeout, including study-file maintenance, routine monitoring, vendor liaison, source document review, trip reporting, and assigned project responsibilities.
- Protected participant safety and data integrity by verifying informed consent compliance, protocol adherence, CRF accuracy, query resolution, and follow-up of safety events.
- Served as lead monitor/local project coordinator as assigned, supporting monitoring plans, investigator meetings, feasibility, investigator recruitment, EC submissions, regulatory notifications, budgets, and agreements.
- Collaborated with investigative sites and client personnel; supported mentoring/co-monitoring and contributed to protocol, CRF, and clinical trial report development.
- Monitored an overactive bladder clinical trial from site initiation through closeout; routine FDA audit following NDA submission resulted in no findings.
Clinical Research Associate - ADN Research - Springfield, OR, USA
(2001-09 - 2004-12)
- Managed routine monitoring, closeout, study-file maintenance, pre-study visits, initiation visits, vendor liaison, and project activities.
- Protected participant safety and data integrity by verifying informed consent compliance, protocol adherence, source document accuracy, CRF review, query resolution, and follow-up of missing or implausible data.
- Supported SAE reporting, trip reports, feasibility, investigator recruitment, EC submissions, regulatory notifications, study documentation translation, meetings, budgets, and agreements.
- Assisted with training, mentoring, co-monitoring, vendor coordination, clinical trial reporting, and designated local project coordination responsibilities.
Clinical Research Associate - Oregon Center for Clinical Investigations - Eugene, OR, USA
(2000-04 - 2001-09)
- Performed initiation, interim, and close-out visits
- CRF review and source verification
- Assisted and trained site staff in proper reporting of protocol violations and retraining of site staff to eliminate future errors with implementation of site additional SOPs
- Supported the FDA investigator during a routine audit of a high-enrollment attention deficit hyperactivity disorder trial following NDA submission.
- Previously responsible for composition, submission, review, and maintenance of site regulatory documentation for 25 trials conducted across three sites.
Certified Clinical Research Coordinator - Oregon Center for Clinical Investigations - Eugene, OR, USA
(1999-04 - 2000-04)
- Supported the informed consent process.
- Performed routine triage of trial subjects, including vital signs, ECG administration, and phlebotomy
- Created and implemented a tracking system of regulatory documentation for three sites
- Led revisions of site SOPs to strengthen compliance with ICH-GCP guidelines and 21 CFR requirements.
- Performed telephone screening of potential subjects for various indications
Certified Clinical Research Coordinator - Orthopedic Healthcare Northwest - Eugene, OR, USA
(1994-01 - 1999-04)
- Led revisions of site SOPs to strengthen compliance with ICH-GCP guidelines and 21 CFR requirements.
- Assisted in the informed consent process
- CRF completion and submission
- Resolved data queries and supported timely clarification of source documentation.
- Assisted FDA investigator on two separate occasions during routine audit of high enrollment lumbar threaded interbody fusion devices (2 separate studies) following submission for approval
- Managed regulatory submissions and maintained study-related essential documents.
