Senior Clinical Research Associate

🔥 16 hours ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Manage project activities associated with monitoring Phase I through Phase IV clinical research and Real World Evidence studies • Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits and complete visit deliverables • Assist with feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Complete required 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 and provide site status updates to the Clinical Project Manager • Conduct remote monitoring according to study-specific Monitoring Plans • Track subject status, CRF retrieval/SDV, regulatory documents, and investigational product using systems and reports • Support project-specific activities and development of CRFs and study-related documents • Support translation, customization, and review of patient information sheets, informed consent, protocol synopsis, and other documents • Support regulatory submission documentation and follow up through approval where applicable • Provide regular updates to the Sponsor/Client • Assist with and attend investigator and client meetings • Liaise with Clinical Data Management for data cleaning • Identify site issues, implement corrective actions, or escalate as appropriate • Manage ISF and TMF for assigned study sites • Support contract negotiation, investigator payments, and site payment tracking where applicable

🎯 Requirements

• 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 • 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 conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO • Successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred • Knowledge of drug development process, ICH/GCP, and relevant regulations • Ability to adhere to regulatory guidelines and Standard Operating Procedures (SOPs)

🏖️ Benefits

• Structured mentoring program and leadership courses • Tuition reimbursement • Dedicated training department • Generous health benefits • Vacation packages • Hybrid work-from-home opportunities • Paid parental leave • CTI Cares program • Work-life balance support