Driven Senior Clinical Research Associate with a proven track record at IQVIA for enhancing project outcomes. Well organized and thorough with good planning and problem-solving abilities significantly contributing to timely and accurate clinical research results. Excelled in guiding sites to ensure protocol objectives and study integrity. Skilled in fostering team collaboration and mentoring colleagues with skills developed over more than 20 years in the field.
· Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
· Conducted monitoring and closeout visits to verify study procedures, patient safety and accurate timely data completion.
· Worked with principal investigator and sponsors to facilitate trial activities and compliance with research protocols, SA-GCP, ICH-GCP and FDA regulations.
· Collaborated with the research sites to ensure the essential documents were maintained and current.
· Followed study medication storage procedures to comply with protocols and SOP requirements.
· Communicated project status to management verbally and through technical documentation and presentations.
· Managed projects from procurement to completion
· Met project deadlines without sacrificing quality or safety.
· Sourced, vetted and managed vendors needed to accomplish project goals.
· Recruited, trained and oversaw personnel to achieve performance and quality targets within budget requirements.
· Tracked project and team member performance closely to quickly intervene in mistakes or delays.
· Coordinated with study teams to resolve project issues and mitigate risks.
· Provided detailed operational direction in project challenges, consistently meeting deliverables according to deadlines.
· Facilitated workshops by presenting regular updates on project status.