- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
- Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client
- Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
- Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate
- Liaise with Clinical Data Management for data cleaning activities
- Serve as mentor / trainer for CRAs; may include conducting training/assessment visits
- Function in the role of Lead CRA for assigned project(s)
- 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), or similar systems
- Ability to understand complex medical terminology and procedures
- 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 CRAs
- At least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
- 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
- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
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Clinical Research Associate
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Senior Clinical Research Associate - Covington, United States - CTI
Description
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.What You'll Do:
