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About the Role
This role involves overseeing clinical monitoring activities, serving as a primary point of contact for projects, and ensuring the quality and timeliness of clinical data and deliverables.
Responsibilities
- Review project scope and resourcing for Clinical Monitoring.
- Plan, schedule, and implement clinical monitoring aspects of projects.
- Define and implement functional standards, goals, and expectations for the Clinical Monitoring team.
- Serve as the primary point of contact for Clinical Monitoring for designated projects.
- Act as an advocate for the Clinical Monitoring team with the client.
- Coordinate and oversee daily operations of the Clinical Monitoring team, including CRAs and in-house personnel.
- Ensure CRAs receive appropriate therapeutic and project-specific training.
- Develop CRA tools and training materials.
- Organize and conduct CRA meetings/calls as needed.
- Ensure accurate tracking of clinical monitoring deliverables.
- Oversee key clinical monitoring metrics and ensure they are met.
- Provide oversight of visit report review and approval, including issue escalation and resolution.
- Manage clinical monitoring related project milestones and address deficiencies.
- Oversee the quality and timeliness of clinical data in the eDC.
- Oversee core clinical portions of the Trial Master File.
- Participate in clinical monitoring risk planning and assessment, developing mitigation strategies.
- Ensure all clinical monitoring/site management related closeout activities are completed.
- Mentor CRAs to ensure high performance and productivity.
- Provide feedback on CRA performance to line managers.
- Serve as CRA trainer/mentor and accompany CRAs on field visits.
- Develop successful cross-functional relationships.
- Undertake specific CPM tasks as agreed with Line Manager.
- Oversee CRA timesheets for hours exceeding budget and escalate.
- Serve as a contact/resource for investigative sites.
- Conduct on-site or remote monitoring activities as needed.
- Act as the primary monitoring point of contact for sponsors and sites for smaller projects.
- Participate in Bid Defense planning and meetings.
- Assist with other duties as assigned.
Requirements
- At least 8 years as CRA or equivalent clinical research experience.
- Prior proficient performance as Lead CRA for at least 1 year.
- Maintained previous role performance KPIs and metrics at fully performing or exceeds level for at least 2 years.
- Demonstrated successful performance at Senior CRA level, with at least 4 of the required 8 years as CRA, of experience monitoring complex studies.
- Experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.
- Fluent in English.
Work Type
- Hybrid work opportunities
Experience Level
- At least 8 years as CRA
- At least 1 year as Lead CRA
- At least 4 years monitoring complex studies as Senior CRA
Education Level
- Bachelor's Degree or higher in allied health field (nursing, pharmacy, health/natural science)
- RN with Associate's Degree
- 3-year Nursing Diploma with at least 2 years clinical nursing experience
- Equivalent experience as determined by CTI Management and Human Resources
Benefits
- Structured mentoring program
- Leadership development courses
- Dedicated training department
- Support for ongoing education
- Award-winning culture that prioritizes people
- Support for work-life balance
- Opportunities to give back to the community through CTI Cares program
About the Company
- Advance Your Career: We invest in your professional growth through structured mentoring, leadership development, and a dedicated training department.
- Join an Award-Winning Team: Be part of a global team spanning 60 countries, recognized for its people-centric, award-winning culture.
- Make a Lasting Impact: Your work directly contributes to advancing medicine and developing life-changing treatments for patients.