Senior Clinical Research Associate

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Act as the primary CTI liaison for designated study sites

• Carry out pre-study assessments, site initiation, interim monitoring, and close-out visits

• Accurately complete site visit deliverables within the timelines outlined in the Monitoring Plan

• Assist in study start-up, feasibility assessments, pre-study tasks, and site selection processes

• Collect, review, and monitor essential and regulatory documentation

• Participate in meetings with investigators, clients, and project teams

• Develop and execute strategies for subject enrollment

• Ensure appropriate storage, distribution, and accountability of Investigational Product and trial-related materials

• Conduct site management tasks and provide site status updates to the Clinical Project Manager

• Perform remote monitoring in accordance with study-specific Monitoring Plans

• Monitor subject status, CRF retrieval, source document verification, regulatory documents, and Investigational Product using various systems and reports

• Assist with project-specific activities and the development of CRFs and study documentation

• Aid in the translation, customization, and review of patient information, informed consent forms, protocol synopses, and other study-related documents

• Support the preparation of regulatory submission documentation and follow up on approval processes as necessary

• Provide regular updates to the Sponsor/Client

• Assist with and attend meetings with investigators and clients

• Collaborate with Clinical Data Management on data cleaning efforts

• Identify site-related issues, implement corrective measures, or escalate concerns as needed

• Manage the Investigator Site File and Trial Master File for assigned sites

• Assist in contract negotiations, investigator payments, and site payment tracking where applicable

⛳️ Requirements

• A minimum of 1 year of clinical trial monitoring experience or equivalent qualifications 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 an RN with an Associate's Degree; or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent qualifications as determined by CTI Management and Human Resources

• Prior experience conducting clinical research studies in a hospital environment, pharmaceutical company, or CRO

• Proven successful performance in a CRA role

• At least 1 year of on-site monitoring experience preferred

• Compliance with relevant regulatory requirements, SOPs, and ICH GCP

• Capability to complete both general and study-specific training

• Familiarity with clinical trial systems and reports, CRFs, SDV, regulatory documents, IP, ISF, and TMF

• Ability to assist with regulatory submissions and contract negotiations where applicable

🏝️ Benefits

• Structured mentoring program

• Leadership courses

• Tuition reimbursement

• Dedicated training department

• Generous health benefits

• Vacation packages

• Hybrid work-from-home options

• Paid parental leave

• CTI Cares program

• Support for work-life balance