Diana Swanson

Clinical research professional with 20+ years of experience supporting Phase I-IV pharmaceutical, biotechnology, CRO, and clinical research programs. Brings senior-level expertise in clinical monitoring, CRA oversight, site management, monitoring quality review, inspection readiness, and regulatory compliance across neurology, psychiatry, oncology, infectious disease, cardiometabolic, and device studies. Deep expertise in Central Nervous System (CNS) clinical trials, including Generalized Anxiety Disorder (GAD), Major Depressive Disorder (MDD), Panic Disorder, Schizophrenia, ADHD, Alzheimer’s Disease, Parkinson’s Disease, Migraine, and other neurological and psychiatric indications.

Proven track record conducting and overseeing monitoring activities, reviewing monitoring visit documentation, identifying protocol deviations and compliance risks, mentoring and co-monitoring CRAs, and ensuring adherence to ICH-GCP, FDA regulations, Clinical Monitoring Plans (CMPs), and Standard Operating Procedures (SOPs). Recognized for strengthening monitoring quality, maintaining inspection-ready trial documentation, supporting audit readiness, and partnering with Clinical Operations and Quality teams to improve consistency, compliance, and operational excellence.

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.

Coursework - Treasure Valley Community College

Coursework - Highline Community College

Radiology - Western States Chiropractic College