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.

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

• Ensure that site visit deliverables are completed accurately and within the timelines outlined in the Monitoring Plan.

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

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

• Complete both general and study-specific training sessions.

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

• Develop and execute strategies for subject enrollment.

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

• Execute site management tasks and keep the Clinical Project Manager informed about site status.

• Carry out remote monitoring in accordance with study-specific Monitoring Plans.

• Monitor subject status, CRF retrieval, source document examinations, regulatory documents, and investigational products using various systems and reports.

• Contribute to project-specific initiatives as a member of the Project Team.

• Assist in the development of CRFs and other related study documents.

• Facilitate the translation, customization, and review of patient information sheets, informed consent documents, protocol synopses, and additional study documents.

• Support the documentation for regulatory submissions and follow up through the approval process where necessary.

• Provide regular updates to the Sponsor/Client.

• Organize and assist with investigator and client meetings.

• Collaborate with Clinical Data Management on data cleaning efforts.

• Identify site-related issues, implement corrective actions, or escalate matters as needed.

• Manage the ISF and TMF for the assigned study sites.

• Assist in negotiating study-site contracts, managing investigator payments, and tracking site payments where applicable.

⛳️ Requirements

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

• 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 experience.

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

• Preferred: Successful CRA performance with at least 1 year of on-site monitoring experience.

• Familiarity with the drug development process, ICH/GCP guidelines, and relevant regulations.

• Capability to perform site management activities in compliance with regulatory guidelines and SOPs.

• Ability to conduct visits at clinical study sites and perform remote monitoring.

• Proficiency in managing essential documents, ISF, and TMF.

• Competence in working with CRFs, source document verification, investigational products, and trial materials.

• Capacity to support regulatory submissions, data cleaning, site contracts, and investigator payments where applicable.

🏝️ Benefits

• Up to $10K sign-on bonus.

• Structured mentoring program.

• Leadership development courses.

• Tuition reimbursement.

• Dedicated training department.

• Comprehensive health benefits.

• Vacation packages.

• Opportunities for hybrid work-from-home arrangements.

• Paid parental leave.

• CTI Cares program.

• Support for work-life balance.