Senior Clinical Research Associate (level dependent on experience)

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 65,000 - 100,000; Full time

Benefits offered by this job

Hybrid work-from-home opportunities

Health benefits

Vacation packages

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services is seeking a Clinical Trial Monitor to manage site activities across phase I–IV studies and Real World Evidence projects. You will perform on-site visits (PSV, SIV, IMV, COV), ensure regulatory compliance, and support start-up, data management, and investigator communications.

You will bring 1 year of on-site monitoring experience and a health-related degree, with hybrid work options and opportunities for professional growth within a global team.

Qualifications

• > 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, nursing, pharmacy, or health/science background; RN with an Associate's; or equivalent CTI-defined experience
• > Experience in hospital, pharmaceutical company, or CRO settings with on-site monitoring preferred

Responsibilities

• Serve as the main CTI contact for assigned study sites
• Conduct site visits (PSV, SIV, IMV, COV) and deliverables within Monitoring Plan timelines
• Assist with start-up activities including feasibility and site selection
• Collect, review, and track essential regulatory documents
• Participate in training and meetings for investigators, clients, and project teams
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation, and accountability of Investigational Product
• Manage site status updates to the Clinical Project Manager
• Conduct remote monitoring per study Monitoring Plan
• Liaise with Clinical Data Management for data cleaning and issue resolution
• Support in contract negotiation with sites and investigator payments

Skills

Clinical trial monitoring

Site management

Regulatory compliance

GCP/ICH familiarity

Communication

Education

Bachelor's degree or higher

RN/health professional background

Nursing diploma or equivalent

Tools

Regulatory documents handling

Job description

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

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

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.