Senior Clinical Research Associate

🕒 July 28

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits • Complete site visit deliverables accurately and within Monitoring Plan timelines • Assist with study start-up, feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Complete general and study-specific training • Participate in investigator, client, and project team meetings • Create and implement subject enrollment strategies • Ensure proper storage, dispensation, and accountability of investigational product and trial materials • Perform site management activities and update the Clinical Project Manager on site status • Conduct remote monitoring according to study-specific Monitoring Plans • Track subject status, CRF retrieval, source document review, regulatory documents, and investigational product using systems and reports • Support project-specific activities as a Project Team member • Support development of CRFs and other study-related documents • Support translation, customization, and review of patient information sheets, informed consent documents, protocol synopses, and other study documents • Support regulatory submission documentation and follow up through approval where applicable • Provide regular updates to the Sponsor/Client • Assist with and coordinate investigator and client meetings • Liaise with Clinical Data Management on data cleaning • Identify site issues, implement corrective actions, or escalate as appropriate • Manage ISF and TMF for assigned study sites • Support study-site contract negotiation, investigator payments, and site-payment tracking where applicable

🎯 Requirements

• At least 1 year of clinical trial monitoring experience or equivalent experience • 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 of clinical nursing experience, or equivalent experience • Previous experience conducting clinical research studies in a hospital, pharmaceutical company, or CRO • Successful CRA performance with a minimum of 1 year of on-site monitoring experience preferred • Knowledge of the drug development process, ICH/GCP, and relevant regulations • Ability to perform site management activities in accordance with regulatory guidelines and SOPs • Ability to conduct clinical study site visits and remote monitoring • Ability to manage essential documents, ISF, and TMF • Ability to work with CRFs, source document verification, investigational product, and trial materials • Ability to support regulatory submissions, data cleaning, site contracts, and investigator payments where applicable

🏖️ Benefits

• Up to $10K sign-on bonus • Structured mentoring program • Leadership courses • Tuition reimbursement • Dedicated training department • Health benefits • Vacation packages • Hybrid work-from-home opportunities • Paid parental leave • CTI Cares program • Work-life balance support