Senior Clinical Research Associate

🔥 15 hours ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 • 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-related materials • Perform site management activities and provide site status updates to the Clinical Project Manager • Conduct remote monitoring according to study-specific Monitoring Plans • Track subject status, CRF retrieval, source document verification, regulatory documents, and Investigational Product using systems and reports • Support project-specific activities and development of CRFs and study documents • Support translation, customization, and review of patient information, informed consent, protocol synopsis, 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 attend investigator and client meetings • Liaise with Clinical Data Management on data cleaning • Identify site issues, implement corrective actions, or escalate issues • Manage the Investigator Site File and Trial Master File for assigned 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; or 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 • Demonstrated successful performance in a CRA position • Minimum of 1 year of on-site monitoring experience preferred • Adherence to applicable regulatory requirements, SOPs, and ICH GCP • Ability to complete general and study-specific training • Experience with clinical trial systems and reports, CRFs, SDV, regulatory documents, IP, ISF, and TMF • Ability to support regulatory submissions and contract negotiation where applicable

🏖️ Benefits

• Structured mentoring program • 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