John Richards Email & Phone Number

-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.

-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.

- 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.

- 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.

-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.

Doctor Of Medicine - Md, Medicine

Bachelor Of Science - Bs, Biology, General