John Richards Email and Phone Number
A Journey of Transformative Impact in Clinical ResearchFrom my earliest days as a Clinical Research Coordinator to my current role as a Lead Clinical Research Associate, I’ve been on a journey of continuous growth and transformation in the clinical research field. Along the way, I’ve discovered the power of innovation, precision, and collaboration in advancing groundbreaking therapies, particularly in rare diseases, oncology, neuroscience and other therapeutic areas.Breakthrough MomentsMy career is marked by pivotal achievements that reflect my dedication to operational excellence:- Patient-Centric Solutions: Exceeded patient recruitment goals by 15% in a Phase II pediatric neuromuscular trial, contributing to critical advancements in treatments for Duchenne muscular dystrophy. - Regulatory Excellence: Spearheaded initiatives that resulted in a 20% reduction in protocol deviations and a 17% decrease in audit findings, ensuring regulatory compliance and study integrity. - Data-Driven Decisions: Designed and delivered eCRF training that reduced data query rates by 25%, saving 10 hours per site monthly and improving data quality across multiple sites. Therapeutic ExpertiseMy clinical research experience spans a diverse range of therapeutic areas, including: - Rare Diseases: Duchenne muscular dystrophy and cystic fibrosis. - Oncology : NSCLC, breast cancer, melanoma, and other targeted therapies. - Neuroscience : neuromuscular disorders and pediatric neuroscience. - Cardio-Metabolic Disorders: heart failure, Type 2 diabetes, and obesity. - Medical Devices/IVD : Overseeing trials for innovative diagnostic and therapeutic devices. #### **Driving Results in a Dynamic Industry**I thrive in the nuanced ecosystem of clinical research, navigating the complexities of small startups and large biotech companies alike. My expertise in **CRO oversight, site management, unblinded studies, and data analysis** has been instrumental in delivering results. For instance, I have led the initiation and execution of multiple clinical studies, achieving 100% audit readiness and reducing audit findings by 23%.#### **Vision for the Future**Looking ahead, I aim to continue driving innovation and collaboration to streamline clinical trial operations, enhance patient outcomes, and contribute to the development of life-changing therapies. My ultimate goal is to leverage my expertise to mentor emerging professionals in the field, fostering a culture of excellence and integrity in clinical research.
Bicara Therapeutics
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Lead Clinical Research AssociateBicara Therapeutics Jul 2022 - Present-Led the initiation, planning, execution, maintenance, and close-out of multiple clinical studies, ensuring adherence to timelines and budget constraints.-Developed and maintained essential study documents and trackers, enhancing efficiency in site and study management activities.-Provided comprehensive oversight of contract vendors and CRO activities, ensuring compliance with study plans, SOPs, and regulatory guidelines.-Collaborated with the Associate Director to develop clinical monitoring plans, conducting and overseeing co-monitoring activities for QA and staff training.-Proactively identified and escalated study-related issues, participating in problem-solving and risk mitigation strategies.-Contributed to regulatory submissions by reviewing and coordinating approvals of clinical documents.Ensured the quality and integrity of clinical data through meticulous review and resolution of data queries.
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Senior Clinical Research AssociateZymeworks Inc. May 2019 - Jul 2022-Conducted selection, initiation, monitoring, and closeout visits for various clinical studies, ensuring compliance with the Clinical Monitoring Plan.-Drove site performance, identifying and resolving study-related issues in a timely manner, and escalated them as needed.-Trained and advised investigators and site staff on study-related matters, including Risk-Based Quality Management principles.-Developed site-specific recruitment plans, managing and supporting enrollment to meet milestones, and documented recruitment barriers and solutions.-Monitored and ensured adherence to monitoring KPIs, maintaining them within acceptable quality ranges.-Prepared and finalized monitoring visit reports, providing feedback to Principal Investigators in accordance with company SOPs.-Ensured timely collection and uploading of essential documents into the eTMF in line with ICH-GCP and local requirements. -
Clinical Research Associate IiAbbott Aug 2017 - May 2019- Employed risk-based monitoring approaches, including root cause analysis and critical thinking, to identify and rectify site process failures, ensuring compliance and risk mitigation.- Conducted on-site and remote monitoring activities, ensuring data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and CRF review.- Managed investigational product inventory and records, ensuring proper handling and storage in line with study protocols.- Documented observations in reports and escalated deficiencies to clinical management promptly, ensuring resolution of issues.- Maintained regular contact with investigative sites to monitor protocol adherence and issue resolution.Participated in the investigator payment process and collaborated with project team members to resolve issues/findings. -
Clinical Research Associate IAllergan Feb 2016 - Aug 2017- Conducted qualification, initiation, monitoring, and closeout visits for research sites, ensuring compliance with approved protocols.- Maintained effective communication with medical site staff, including coordinators and clinical research physicians, to facilitate smooth study operations.- Verified investigator qualifications and ensured the availability of necessary resources, including facilities, laboratories, and equipment.- Conducted thorough medical record and research source documentation verification against case report form data, addressing entry errors and ensuring adherence to good documentation practices.- Ensured only eligible subjects were enrolled in studies, in line with protocol criteria.- Performed regulatory document reviews and managed medical device and investigational product/drug accountability.- Monitored and reviewed adverse events and serious adverse events, verifying accurate data reporting as per the protocol.- Assessed clinical research sites' patient recruitment and retention, providing recommendations for improvement. -
Clnical Research CoordinatorHouston Methodist Jan 2015 - Feb 2016-Served as a key member of the project team, supporting the quality execution of clinical protocols in line with SOPs and ICH/GCP guidelines.-Assisted in protocol development and management of study-related vendors, ensuring high data quality.-Supported the Study Lead in developing study timelines, and budgets, and managing study processes.-Conducted sponsor oversight visits and participated in the recruitment of potential investigators.-Contributed to the design and compliance of clinical monitoring plans and CRF design processes.-Managed and updated regulatory files for assigned sites, liaising with internal teams to ensure drug supply and data quality.
John Richards Education Details
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Medicine -
Biology, General
Frequently Asked Questions about John Richards
What company does John Richards work for?
John Richards works for Bicara Therapeutics
What is John Richards's role at the current company?
John Richards's current role is Innovative Lead CRA | Transforming Clinical Trial Operations in Rare Disease & Pediatric Neuromuscular Studies | Unblinded Study Specialist.
What schools did John Richards attend?
John Richards attended University Of Port Harcourt, University Of Port Harcourt.
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