What You'll Do
- Review scope of project 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 Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon
- Primary point of contact for Clinical Monitoring aspects of designated projects
- Serve as advocate for the Clinical Monitoring team with the client
- Coordinate and oversee daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training
- Develop CRA tools and CRA training materials
- Organize and conduct CRA meetings/calls if in project scope
- Ensure accurate tracking of any relevant study information related to Clinical Monitoring deliverables
- Oversight of 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 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
- Active involvement 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
- As necessary serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits.
- Develop successful cross-functional relationships with internal and external team members.
- May be required to undertake specific CPM tasks, as agreed with Line Manager
- Ability to understand and oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager
- May serve as a contact/resource for investigative sites as required
- May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre-study and Site Initiation Visits during project startup
- May 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
What You'll Bring
- 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
- At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager
- 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
- 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
- Experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
Why CTI?
- We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
- We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled – Click here to learn more about “The CTI Way”
- We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- We will never communicate with you directly via Microsoft Teams Messaging or text message
- We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
8+ years as CRA or clinical research experience, 1+ year as Lead CRA, 4+ years monitoring complex studies, Bachelor's in allied health or RN with Associate's, expert ICH/GCP knowledge, CTMS/eTMF/EDC proficiency.
Key Responsibilities
- managing clinical monitoring
- overseeing CRA team
- ensuring data quality
Skills & Tools
Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Microsoft Excel, Microsoft PowerPoint, Microsoft Word
Job Details
- Category: Project and Program Management
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — United States
- Languages: English
Benefits
- Tuition reimbursement
About CTI Clinical Trial and Consulting Services
A clinical research organization providing clinical trial management and monitoring services. — Industry: Research and Development