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About the Role
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the development lifecycle, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
Responsibilities
- Review project scope and resourcing related to Clinical Monitoring with Clinical Project Management.
- Plan, schedule, and implement the clinical monitoring aspects of projects.
- Define and implement project-specific functional standards, goals, and expectations with the Clinical Monitoring team, including KPIs, KRIs, QTLs, and additional agreed-upon metrics.
- Serve as the primary point of contact for Clinical Monitoring aspects of 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, ensuring assigned CRAs receive therapeutic and project-specific training.
- Develop CRA tools and training materials.
- Organize and conduct CRA meetings/calls if within project scope.
- Ensure accurate tracking of relevant study information related to Clinical Monitoring deliverables.
- Oversee key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed up on as necessary.
- Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure.
- Manage clinical monitoring related project milestones and proactively address deficiencies.
- Oversee the quality and timeliness of clinical data in the eDC per the Clinical Trial Monitoring Plan.
- Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and maintained in accordance with SOPs.
- Actively participate in clinical monitoring risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation, and resolution.
- Ensure all clinical monitoring/site management related closeout activities are completed.
- Mentor CRAs as needed on the Clinical Project team to ensure high performance and productivity.
- Provide feedback/information on CRA performance as requested by CRA line managers.
- Serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits as necessary.
- Develop successful cross-functional relationships with internal and external team members.
- Undertake specific CPM tasks as agreed with Line Manager.
- Oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager.
- Serve as a contact/resource for investigative sites as required.
- Conduct on-site or remote monitoring activities as needed, including Pre-study and Site Initiation Visits during project startup.
- Act as the primary monitoring point of contact for sponsors and sites for smaller or single service projects.
- Participate in Bid Defense planning and Bid Defense Meetings as requested.
- Assist with other duties as assigned.
Requirements
- Excellent verbal and written communication skills.
- Excellent organizational and time management skills.
- Excellent critical thinking and decision-making skills; proactively identify challenges and potential risks.
- Excellent collaboration, customer service, and interpersonal skills.
- Ability to work independently.
- Proficient in use of laptop computer and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Microsoft Excel/PowerPoint/Word, or similar systems.
- Ability to understand complex medical terminology and procedures.
- Ability to review and explain study budgets to CRA and CMAs.
- Ability to monitor complex indications.
- Expert knowledge of ICH/GCP and all applicable regulatory requirements.
- Ability to mentor and provide constructive feedback to lesser experienced individuals.
- At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager.
- Prior proficient performance as CTM 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.
Skills
- Clinical Monitoring
- Clinical Project Management
- KPIs
- KRIs
- QTLs
- CTMS
- eTMF
- EDC
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Word
- ICH/GCP
- Regulatory Requirements
- Mentoring
- Communication
- Organization
- Time Management
- Critical Thinking
- Decision-Making
- Collaboration
- Customer Service
- Interpersonal Skills
- Independent Work
- Medical Terminology
- Study Budgets
- Complex Indications Monitoring
Location
- Greater Cincinnati, OH region
Work Type
- Hybrid work from home opportunities
Experience Level
- At least 8 years as CRA or other experience in clinical research
- Prior proficient performance as CTM for at least 1 year
- Demonstrated successful performance at Senior CRA level with at least 4 years as CRA
Education Level
- Bachelor's Degree or higher in 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 clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
Benefits
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- Tuition reimbursement
- Structured mentoring program
- Leadership courses
- Dedicated training department
About the Company
- CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
- We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
- CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
- We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.