Senior Clinical Research Associate (level dependent on experience)

Ctifacts; United States; Hybride; USD 90 000 - 120 000; Plein temps

Résumé du poste

CTI Clinical Trial and Consulting Services is seeking a Senior Clinical Research Associate (level dependent on experience) for its United States remote position. You will serve as the main CTI contact for study sites, conduct site visits across PSV/SIV/IMV/COV, and manage regulatory documents in alignment with ICH GCP and SOPs.

Responsibilities include supporting start-up activities, training, budget and site collaboration, and ensuring IP/material accountability.

Qualifications

• At least 1 year of clinical trial monitoring experience.
• Bachelor's degree or higher in nursing, pharmacy or health/sciences; RN with an Associate's Degree or 3-year Nursing Diploma with at least 2 years nursing experience.

Responsabilités

• Serve as the main CTI contact for assigned study sites.
• Conduct site visits (PSV, SIV, IMV, COV) and complete site visit deliverables within timelines.
• Assist with study start-up activities, including feasibility, pre-study activities, and site selection.
• Collect, review, and track essential regulatory documents.
• Participate in investigator, client, and project team meetings.
• Create and implement subject enrollment strategies for assigned sites.
• Ensure storage, dispensation, and accountability of Investigational Product and trial materials.

Connaissances

Clinical trial monitoring

Site coordination

Communication

Formation

Bachelor's degree or higher in allied health field (nursing/pharmacy/health sciences)

Description du poste

Senior Clinical Research Associate (level dependent on experience)

Job Category: Clinical Monitoring

Requisition Number: SENIO002087

• Full-Time
• Remote

Locations

Showing 1 location

United States - Remote

Description

What you'll do:

• Serve as the 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 the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP
• Assist with 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
• 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 the Clinical Project Manager
• Conduct remote monitoring and complete the related activities in accordance with study 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 a member of the Project Team
• May support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures
• Where applicable, provide support to the 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 on the evaluation process until approval is available. Provide regular updates to the Sponsor/ Client

Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary

• Liaise with Clinical Data Management for data cleaning activities
• Identify site issues and implement corrective actions or elevate as appropriate
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments

What You'll Bring:

• At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an 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 a hospital setting, a pharmaceutical company, or a CRO
• Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred

About CTI

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. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.