Clinical Research Coordinator managing the conduct of clinical trials at Emory University. Handling administrative activities and overseeing research project requirements and compliance.
About the role
- Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
Responsibilities
- To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate
- To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues.
- To act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval.
- To observe and escalate safety trends in patients as identified in visit report
- Regular oversight of OMR , ICO trial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary
- Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards .
- Where required , attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends • Liaise with CTM to communicate any trends , outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety.
Requirements
- Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree preferred).
- Minimum 8-10 years of Clinical Research experience with at-least 5 years of on-site monitoring experience.
- Experience in On-Site Monitoring and Clinical Trial Management, with a solid understanding of on-site monitoring approaches.
- Strong analytical skills with proficiency in clinical trial data review and interpretation.
- Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines.
- Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
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