8+ years of experience in clinical research, with at least 4 years as a CRA monitoring complex studies
Proven track record as a Lead CRA for a minimum of 1 year
Bachelor's Degree in allied health or equivalent experience
Expert knowledge of ICH/GCP and regulatory requirements
Strong critical thinking and decision-making skills
Ability to mentor and provide feedback to junior staff
Proficient in CTMS, eTMF, EDC, and Microsoft Office Suite
Responsibilities
Review project scope and resources related to Clinical Monitoring
Plan and implement clinical monitoring aspects of projects
Define project-specific standards and metrics with the Clinical Monitoring team
Serve as the primary contact for Clinical Monitoring on designated projects
Coordinate daily operations of the Clinical Monitoring team and ensure training for CRAs
Oversee clinical monitoring metrics and ensure compliance with quality standards
Mentor CRAs and provide performance feedback as needed
Benefits
Opportunities for professional development and training
Collaborative work environment with cross-functional teams
Potential for involvement in high-impact clinical projects
Supportive management focused on employee growth
Access to advanced clinical research tools and technologies
Full Job Description
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
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 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
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