Ralf W. Brooks
Pace,Florida
Summary
Senior Clinical Research Consultant bringing 20 years of global clinical trial experience across monitoring oversight, quality assurance, risk-based quality management, and regulatory compliance. Recognized for strengthening monitoring performance, proactively mitigating systemic risks, and leading CAPA strategies to protect data integrity and patient safety. Strategic partner to study teams, CROs, and executive leadership, advancing inspection readiness through SOP governance, training, performance metrics, and audit and inspection support in alignment with ICH-GCP and regulatory requirements.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Sr. Manager, Quality Assurance, temp assignment with Beacon Hill
Alnylam
Cambridge, USA
10.2025 - Current
- Strategic Clinical Quality leader with a track record of building scalable governance frameworks, strengthening inspection readiness, and mitigating regulatory risk across global trial portfolios through robust RBQM.
- Directed global Quality and GCP compliance strategy for Phase I–IV clinical programs, establishing scalable governance frameworks that ensured consistent adherence to FDA, EMA, Health Canada, MHRA, PMDA, and other international regulatory requirements across internal teams, vendors, and investigator networks.
- Led enterprise-wide audit and inspection readiness programs, mitigating risk and preparing organizations for global regulatory inspections, resulting in zero critical observations and a 30% reduction in minor findings across two compound portfolios.
- Managed risk-based monitoring and quality oversight models, utilizing KPIs, KRIs, and trend analytics to identify systemic risks and strengthen controls in trial execution and data integrity.
- Championed CAPA governance, directed root-cause analysis and remediation strategies that embedded continuous improvement and maintained 94% CAPA effectiveness.
- Served as strategic advisor to senior leadership and study teams, shaping quality strategy, operational decisions, and regulatory risk posture across four clinical programs.
- Directed vendor and CRO quality management, overseeing performance, audits, and governance reviews to enhance accountability and minimize regulatory risk exposure.
- Led cross-functional process optimization and global SOP modernization initiatives, increasing operational efficiency, scalability, and sustained inspection readiness.
- Delivered executive-level quality dashboards, risk assessments, and audit insights that supported data-driven decision-making and informed compliance investment strategies.
- Cambridge, MA
Clinical Consultant
Just in Time GCP
Warrington, USA
06.2024 - 10.2025
- Advised clients on inspection readiness and GCP compliance by leading process mapping, SOP and CAPA development, and TMF and data management reviews, enhancing regulatory preparedness and operational efficiency.
- Advised cross-functional client leadership teams on quality and compliance strategy, streamlining governance and documentation practices and reducing regulatory inspection preparation time by 30%.
- Interpreted global health authority inspection trends and translated findings into actionable risk mitigation strategies, strengthening audit and inspection preparedness across five sponsor organizations.
- Designed and implemented standardized compliance assessment frameworks, enabling risk-based prioritization of remediation activities and improving external audit readiness scores by an average of two points per organization.
- Partnered with clients to lead process mapping and operational excellence initiatives, optimizing workflows and closing quality gaps to ensure regulatory adherence.
- Developed and delivered tailored training programs, strengthening stakeholder expertise in ICH-GCP and international regulatory requirements and embedding sustainable compliance practices.
- Partnered with business development teams to design targeted compliance solutions based on analysis of regulatory observations and client feedback, increasing relevance and ROI of service offerings.
- Led internal consulting practice improvements and delivery efficiencies, reducing compliance review cycle times by 33% and increasing overall client satisfaction and engagement outcomes.
- Warrington, Pennsylvania
Contract Senior Clinical Consultant
Formation Bio / TrialSpark
New York, USA
11.2022 - 04.2024
- Managed site initiation and qualification assessments, achieving early participant randomization 21 days ahead of projected timelines and accelerating study start-up efficiency.
- Partnered with cross-functional client teams to optimize clinical operations, implement quality frameworks, and enhance regulatory readiness, driving measurable improvements in data integrity, operational efficiency, and compliance performance.
- Spearheaded query and action item management, resolving >90% of queries within one week and 94% of action items within 30 days, ensuring timely study progression.
- Maintained >95% eTMF completeness and streamlined TMF finalization within two weeks post-site closure, facilitating timely regulatory reviews.
- Sustained data review backlogs below 15%, enabling data lock two months ahead of schedule and improving overall study timelines.
- Accelerated site recruitment through targeted outreach and investigator partnerships, resulting in last patient randomized three months early.
- Directed inspection readiness and compliance initiatives, achieving zero major or critical audit findings while guiding sites on ICH-GCP, FDA CFR, ISO, and HIPAA standards.
- Led root cause analysis and CAPA implementation at underperforming sites, improving operational efficiencies and eliminating repeat risks.
- Developed and delivered training and SOP improvements, boosting team proficiency in CTMS, IVRS, EDC, DDC, and proprietary systems, reinforcing process standardization.
- Implemented direct data collection strategies and optimized resource allocation, reducing study data acquisition time by 64% and lowering overall study costs.
- Collaborated on monitoring plan and workflow optimizations, enabling study completion two months ahead of schedule.
- New York, NY
Director, Monitoring Oversight and Clinical Inspection Readiness
ContraFect
Yonkers, USA
12.2021 - 09.2022
- Led monitoring oversight and inspection readiness for multiple critical inpatient studies following significant internal audit findings, ensuring regulatory compliance and mitigation of operational risk.
- Directed comprehensive site and monitoring evaluations, implementing targeted training and remediation plans that enhanced subject safety, data integrity, and compliance outcomes.
- Developed and delivered study-specific and enterprise-wide training programs based on oversight findings, driving measurable improvements in KPIs and reducing subsequent internal audit observations.
- Managed three clinical trial managers and coordinated twenty field-based clinical research associates to ensure high-quality monitoring oversight and inspection readiness, enhancing compliance across all sites.
- Established robust quality control frameworks that consistently produced favorable audit outcomes, achieving fewer than five minor observations across three consecutive audits.
- Championed cross-functional SOP governance initiatives to strengthen monitoring practices and improve regulatory compliance across clinical programs.
- Oversaw CAPA execution to address recurring non-conformance issues, embedding continuous quality improvement into research activities and enhancing operational integrity.
- Designed KPI and KRI frameworks to proactively identify process gaps and training needs, supporting corrective actions that contributed to zero findings during inspection readiness activities.
- Directed implementation of enterprise-wide Quality Management System, defining project expectations and ensuring compliance across all clinical trials.
- Streamlined TMF reconciliation processes, achieving >95% documentation completeness during active clinical trials and facilitating efficient regulatory review.
- Yonkers, NY
Associate Director, Site Management Operations
AbbVie
Jersey City, USA
02.2017 - 10.2021
- Spearheaded risk-based monitoring strategies, leading comprehensive risk assessments, designing mitigation plans, and executing optimized monitoring protocols, driving enhanced trial efficiency, data integrity, and regulatory compliance.
- Directed clinical operations across multiple therapeutic areas, implementing strategic initiatives that enhanced efficiency, compliance, and team performance.
- Oversaw 60+ monthly monitoring visits, ensuring strict regulatory compliance, enabling rapid feedback loops, and enhancing team accountability.
- Initiated cross-department collaborations to refine risk-based monitoring processes, achieving three key operational improvements that enhanced efficiency and aligned with industry standards.
- Served as a critical liaison between global monitoring and IT teams, leveraging dual expertise to enhance cross-functional collaboration and improve workflow efficiency on high-priority projects.
- Led development of innovative database systems with data management, clinical operations, and compliance teams, enhancing productivity and supporting operational needs.
- Implemented monthly KPI review sessions to provide actionable insights, driving measurable productivity improvements across clinical teams.
- Maintained voluntary turnover rate below 1% through engagement initiatives and emphasis on staff development.
- Optimized human resource budgeting through strategic compensation planning, regional resource alignment, and expense control measures, achieving a 12% reduction in operational costs within one year.
- Strategically allocated regional resources, reducing travel expenses by 15% while maintaining a voluntary turnover rate of under 1% through work-life balance initiatives.
- Performed bi-annual field evaluations of direct reports, delivering focused feedback to strengthen team skills.
- Delivered weekly staff briefings, reducing follow-up questions by over 50% and ensuring team alignment on ongoing studies and corporate initiatives.
- Developed engaging training programs and comprehensive new hire orientations, achieving a 12% reduction in face-to-face training costs while optimizing onboarding efficiency.
- Designed and implemented a structured mentoring framework for Clinical Research Associates, facilitating 25+ mentorship sessions annually, connecting junior staff with senior leadership.
- Coordinated responses to audit findings across eight studies and managed CAPA initiatives, strengthening regulatory preparedness across organizational operations.
- Conducted structured annual performance reviews, tracking progress against benchmarks and doubling internal promotion rates through targeted professional development initiatives.
- (Formerly Allergan), Jersey City, NJ
Principal Regional Site manager, Clinical Trial Manager
Allergan
Jersey City, USA
06.2013 - 02.2017
- Partnered with clinical operations leadership to implement risk-based monitoring strategies, leading comprehensive risk assessments, designing mitigation plans, and executing optimized monitoring protocols, driving enhanced trial efficiency, data integrity, and regulatory compliance.
- Collaborated with project management teams to lead CRA activities, compiling 200+ study data points and distributing updated trackers, ensuring compliance across five clinical studies.
- Facilitated RFP processes and engaged in vendor bid defense meetings for five studies.
- Partnered with management and director-level teams to design data management tools, improving reporting accuracy by 35% and updating SOPs to streamline operations.
- Served as subject matter expert on eTMF, CTMS, EDC, BI, and IVRS platforms, ensuring regulatory compliance and mitigating inspection risks.
- Mentored over 15 new hires, guiding them on policies and procedures to support team integration.
- Developed and delivered comprehensive orientation training, enhancing onboarding efficiency and reducing time to full productivity.
- Designed innovative Risk-Based Monitoring tools and trained colleagues, improving centralized and remote monitoring efficiency and accuracy.
- Spearheaded regulatory document tracker initiatives that improved monitoring operations and ensured ICH/GCP compliance for 15 clinical trials.
- Created and presented materials for investigator meetings on 20 key topics across 10 trials, receiving positive feedback for clarity and engagement.
- Collaborated with research staff to optimize study workflows, reducing average project timelines by 15 days through process improvements.
- Completed protocol training across eight clinical trial protocols, supporting 27 CRAs during co-monitoring visits to minimize source data review backlogs.
- (Formerly Forest Research / Actavis), Jersey City, NJ
Senior Regional Site Manager
Forest Research Institute
Jersey City, USA
09.2011 - 06.2013
- Appointed Subject Matter Expert (SME) for CTMS and EDC systems, leading initiatives to enhance system efficiency and streamline workflows.
- Executed study qualification, initiation, routine monitoring, and close-out visits for 10+ clinical trials, ensuring consistent compliance with ICH/GCP ALCOA+ standards.
- Championed regulatory adherence through robust review protocols for CRFs and source documentation, achieving zero audit findings across three consecutive studies.
- Developed and implemented regulatory document tracking systems, enhancing audit readiness and ensuring operational efficiency.
- Coordinated internal study teams to optimize study management processes, resulting in improved workflow efficiency.
- Collaborated with cross-functional teams to prepare documentation aligned with GCP principles, enhancing efficiency and ensuring patient safety compliance.
- Ensured protocol compliance regarding inclusion/exclusion criteria, maintaining flawless study integrity across multiple trials.
- Maintained precise drug accountability across assigned trials, achieving 100% compliance with inventory protocols and minimizing discrepancies.
- Managed QC review and secure transmission of over 90 regulatory documents monthly.
- Delivered orientation and training sessions for new hires on CTMS and EDC, reducing acclimatization time to complex processes.
- Completed training across 11 study protocols, supporting co-monitoring with regional monitors during database lock initiatives.
- Generated bi-weekly summaries of adverse events/serious adverse events, streamlining communication processes with clinical teams and facilitating timely risk management.
- Achieved 100% compliance for trip report submissions and regulatory documentation through quality management and oversight.
- Jersey City, NJ
CRA II
Covance
Princeton, USA
07.2009 - 09.2011
- Designated Subject Matter Expert (SME) for CTMS and EDC systems, leading initiatives to enhance platform efficiency and optimize team workflows.
- Delivered structured orientation and training programs for new hires on CTMS and EDC platforms, accelerating onboarding and improving team productivity.
- Developed and implemented comprehensive regulatory document tracking systems, streamlining monitoring functions and enhancing audit preparedness.
- Executed study qualification, initiation, routine monitoring, and close-out visits for 10+ clinical trials, ensuring compliance with ICH/GCP ALCOA+ standards and maintaining participant safety across all sites.
- Conducted detailed source data verification of 1800+ CRFs per month, identifying inconsistencies and trends to mitigate risk and ensure participant safety.
- Generated bi-weekly summaries of adverse events and serious adverse events, facilitating timely communication of potential risks to clinical teams.
- Ensured strict adherence to protocol-specific procedures, including inclusion/exclusion criteria, maintaining a flawless compliance record across multiple trials.
- Oversaw QC review and secure transmission of 90+ regulatory documents monthly, ensuring submission accuracy and maintaining zero audit findings.
- Championed adherence to regulatory standards through robust review protocols for CRFs and source documentation, resulting in zero findings across three consecutive studies.
- Completed training across 8 study protocols, supporting co-monitoring efforts with regional monitors during database lock initiatives.
- Collaborated closely with cross-functional teams to prepare documentation aligned with GCP guidelines, streamlining study workflows and improving efficiency.
- Coordinated internal study teams to optimize processes, reducing bottlenecks and ensuring smooth study execution.
- Princeton, NJ
Education
Bachelor of Arts - General Studies Leadership
Southern New Hampshire University
Manchester, NH01.2022
Associate of Science - Applied Management
Kaplan University
Davenport, IA01.2006
Network Engineering and Management -
Computer Learning Centers
Hurst, TX01.2001
Respiratory Therapy Technician -
Naval School of Health Sciences
San Diego, CA01.1992
Hospital Corpsman -
Naval School of Health Sciences
Great Lakes, IL01.1991
Skills
- Atrial Fibrillation
- Congestive Heart Failure
- Dermal Fillers
- Cardiac Devices
- Type II Diabetes
- Hyperthyroid
- Ulcerative Colitis
- Irritable Bowel Syndrome
- Methicillin-resistant Staphylococcus aureus
- Methicillin-Susceptible Staphylococcus Aureus
- Glucose monitoring
- Epilepsy
- Alzheimer’s Disease
- Spasticity
- Multiple Sclerosis
- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Dry Eye
- Presbyopia
- Age-related Macular Degeneration
- Glaucoma
- Osteoarthritis
- Schizophrenia
- Major Depressive Disorder
- Chronic Obstructive Pulmonary Disease
- Adult Respiratory Distress Syndrome
- Asthma
- Cystic Fibrosis
- Phase I – IV
- Umbrella Trials
- Basket Trials
- Pharmaceutical
- Device
- RNA interference
- Gene Therapy
- ICH GCP
- FDA CFR
- EMA CTA
- Health Canada
- MHRA
- PMDA
- PhRMA code
- HIPAA standards
- ATLS
- ACLS
- PALS
- NRP
- BCLS
- Microsoft Windows
- Mac OS
- Microsoft Word
- Excel
- Outlook
- PowerPoint
- Access
- Project
- Visio
- Medidata RAVE
- Oracle InForm
- Veeva Vault EDC
- ClinCapture
- ClinPhone
- Suvoda
- Calyx
- Medidata Rave RTSM
- Veeva Vault CTMS
- Oracle Siebel CTMS
- Medidata Rave CTMS
- Trial Interactive CTMS
- Spotfire
- CluePoints
- Power BI
- QlikView
- Microsoft Power BI
- Consultation management
- Administration reporting
- Financial oversight
- Employee training
- Written communication
- Contract negotiation
- Market analysis
- Decision-making
- Emergency response
- Marketing strategy
- Client relations
- Business planning
- Adaptability
- Active listening
- Fiscal management
- Time management
- Work prioritization
- Negotiation
- Team collaboration
- Problem-solving
- Clinical operations management
- Program development
- Data integrity oversight
- Effective communication
- Influencing and negotiating
- Corporate communications
- Market analysis
- Team coordination
- Resource allocation
- Database development
- Business performance management
- HR management
- Reporting oversight
- Documentation oversight
- Industrial engineering
- Logistics support
- Talent development
- Reporting oversight
- Operations oversight
- Channel analytics
- Team leadership
- Organizational growth
- Equipment decommissioning
- Operations planning
- Material accountability systems
- Cross-functional communication
- Logistics operations management
- Partnership development
- Warehousing functions
- Strategic planning
- Material processing
- Problem resolution
- Innovation management
- Budget administration
- Analytical skills
- Staff management
- Problem resolution
- Team building
Therapeutic Experience
Atrial Fibrillation, Congestive Heart Failure, Acne, Eczema, Psoriasis, Alopecia, Dermal Fillers, Cardiac Devices, Type II Diabetes, Hyperthyroid, Ulcerative Colitis, Irritable Bowel Syndrome, Methicillin-resistant Staphylococcus aureus, Methicillin-Susceptible Staphylococcus Aureus, Glucose monitoring, Epilepsy, Alzheimer’s Disease, Spasticity, Multiple Sclerosis, Non-Small Cell Lung Cancer, Colorectal Cancer, Dry Eye, Presbyopia, Age-related Macular Degeneration, Glaucoma, Osteoarthritis, Schizophrenia, Major Depressive Disorder, Chronic Obstructive Pulmonary Disease, Adult Respiratory Distress Syndrome, Asthma, Cystic Fibrosis
Certification
- Respiratory Care Practitioner
- CNA
- MCP
- MCSE
Professional Development
- ICH GCP
- FDA CFR
- EMA CTA
- Health Canada
- MHRA
- PMDA
- PhRMA code
- HIPAA standards
- ATLS, ACLS, PALS, NRP, and BCLS
Computer Experience
Microsoft Windows, Mac OS all versions, Microsoft Word, Excel, Outlook, PowerPoint, Access, Project, Visio, iMedidata RAVE, Oracle InForm, Veeva Vault EDC, ClinCapture, ClinPhone, Suvoda, Calyx, Medidata Rave RTSM, Veeva Vault CTMS, Oracle Siebel CTMS, Medidata Rave CTMS, Trial Interactive CTMS, Spotfire, CluePoints, Power BI, QlikView, Microsoft Power BI, CluePoints
Timeline
Sr. Manager, Quality Assurance, temp assignment with Beacon Hill
Alnylam
10.2025 - Current
Clinical Consultant
Just in Time GCP
06.2024 - 10.2025
Contract Senior Clinical Consultant
Formation Bio / TrialSpark
11.2022 - 04.2024
Director, Monitoring Oversight and Clinical Inspection Readiness
ContraFect
12.2021 - 09.2022
Associate Director, Site Management Operations
AbbVie
02.2017 - 10.2021
Principal Regional Site manager, Clinical Trial Manager
Allergan
06.2013 - 02.2017
Senior Regional Site Manager
Forest Research Institute
09.2011 - 06.2013
CRA II
Covance
07.2009 - 09.2011
Bachelor of Arts - General Studies Leadership
Southern New Hampshire University
Associate of Science - Applied Management
Kaplan University
Network Engineering and Management -
Computer Learning Centers
Respiratory Therapy Technician -
Naval School of Health Sciences
Hospital Corpsman -
Naval School of Health Sciences