Senior Clinical Research Associate

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

📋 Description

• Oversee project activities related to the monitoring of Phase I through Phase IV clinical research and Real World Evidence studies.

• Act as the primary CTI contact for designated study sites.

• Execute pre-study assessments, site initiation, interim monitoring, and close-out visits, ensuring completion of all visit deliverables.

• Assist with feasibility assessments, pre-study tasks, and the selection of study sites.

• Gather, evaluate, and monitor essential and regulatory paperwork.

• Fulfill mandatory general and study-specific training requirements.

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

• Develop and implement strategies for subject enrollment.

• Guarantee the proper storage, dispensing, and accountability of investigational products and trial materials.

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

• Perform remote monitoring in line with study-specific Monitoring Plans.

• Monitor subject status, CRF retrieval/SDV, regulatory documents, and investigational products using various systems and reports.

• Assist with project-specific tasks and the creation of CRFs and study-related documents.

• Aid in the translation, customization, and review of patient information sheets, informed consent, protocol synopsis, and other materials.

• Support the documentation for regulatory submissions and follow up on approvals where necessary.

• Provide regular updates to the Sponsor/Client.

• Assist in and attend meetings with investigators and clients.

• Collaborate with Clinical Data Management for data cleaning tasks.

• Identify site-related issues, implement corrective measures, or escalate as required.

• Manage the Investigator Site File (ISF) and Trial Master File (TMF) for assigned study sites.

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

⛳️ Requirements

• A minimum of 1 year of experience in clinical trial monitoring 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 sciences.

• RN with an Associate's Degree, or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or equivalent experience as assessed by CTI Management and Human Resources.

• Previous experience in conducting clinical research studies within a hospital, pharmaceutical company, or CRO environment.

• Preferred successful performance in a CRA role with a minimum of 1 year of on-site monitoring experience.

• Understanding of the drug development process, ICH/GCP, and relevant regulations.

• Capability to adhere to regulatory guidelines and Standard Operating Procedures (SOPs).

🏝️ Benefits

• Structured mentoring program and leadership training opportunities.

• Tuition reimbursement options.

• A dedicated training department.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home arrangements.

• Paid parental leave.

• CTI Cares program.

• Support for achieving work-life balance.