
1001 - 5000 employees
Founded 1999
đŒ Consulting
đ„ Healthcare
đ§Ź Biotechnology
Consulting âą Healthcare âą Biotechnology
CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase IâIV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.
đ September 21
đŹđ§ United Kingdom â Remote
â° Full Time
đ Senior
đŽ Lead
đ§Ș Clinical Research
đ» Ghost score 11%
Where this job comes from
Posted on CTI Clinical Trial and Consulting Services's careers page, not through a job board
First seen by Remote Rocketship September 21
Still open on CTI Clinical Trial and Consulting Services's site. Checked 10 hours ago.
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1001 - 5000 employees
Founded 1999
đŒ Consulting
đ„ Healthcare
đ§Ź Biotechnology
Consulting âą Healthcare âą Biotechnology
CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase IâIV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.
âą Review project scope and resourcing related to Clinical Monitoring âą Plan and implement clinical monitoring aspects of projects âą Define and implement project-specific functional standards, goals, expectations, KPIs, KRIs, QTLs, and metrics âą Serve as the primary contact for Clinical Monitoring aspects of designated projects âą Advocate for the Clinical Monitoring team with clients âą Coordinate and oversee daily operations of CRAs and in-house personnel âą Ensure assigned CRAs receive therapeutic and project-specific training âą Develop CRA tools and training materials âą Organize and conduct CRA meetings and calls âą Track study information related to Clinical Monitoring deliverables âą Oversee clinical monitoring metrics, visit reports, action items, query resolution, and quality metrics âą Oversee visit report review and approval, site issue escalation, and resolution âą Manage clinical monitoring milestones and address deficiencies âą Oversee clinical data quality and timeliness in the eDC âą Oversee and maintain core clinical portions of the Trial Master File according to SOPs âą Participate in clinical monitoring risk planning, assessment, mitigation, issue escalation, and resolution âą Ensure completion of clinical monitoring and site-management closeout activities âą Mentor CRAs and provide performance feedback âą Serve as CRA trainer/mentor and accompany CRAs on field training, assessment, oversight, or co-monitoring visits âą Develop cross-functional relationships with internal and external team members âą Undertake specific CPM tasks as agreed with the Line Manager âą Understand and oversee CRA timesheets and escalate budget variances âą Serve as a resource for investigative sites âą Conduct on-site or remote monitoring activities, including pre-study and site initiation visits âą Act as primary monitoring contact for sponsors and sites on smaller or single-service projects âą Participate in bid defense planning and meetings âą Perform other assigned duties
âą At least 8 years as a CRA or other pertinent clinical research experience âą Prior proficient performance as Lead CRA for at least 1 year âą Maintained fully performing or exceeds-level KPIs and metrics for at least 2 years âą Demonstrated successful Senior CRA performance âą At least 4 of the required 8 years as a CRA monitoring complex studies âą Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science; or RN with Associate's Degree; or 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources âą Experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO âą Fluent in English
âą Structured mentoring program âą Leadership development courses âą Dedicated training department âą Ongoing education support âą Hybrid work opportunities âą CTI Cares community and global volunteering opportunities âą Work contributing to life-changing treatments for patients with chronic and critical illnesses
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