Clinical Research Associate

🔥 0 minutes ago

🇸🇦 Saudi Arabia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 • Complete site visit deliverables with quality and within Monitoring Plan timelines • Assist with study start-up activities, feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Participate in 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-related materials • Perform site management activities and provide ongoing site-status updates to the Clinical Project Manager • Conduct remote monitoring according to study-specific Monitoring Plans • Track subject status, CRF retrieval / source document review, regulatory documents, and investigational product • Support project-specific activities as a member of the Project Team • 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 Affairs Study Start-up Team submissions and follow-up with Ethics Committees, Regulatory Authorities, Competent Authorities, or Institutional Administration Boards • Provide regular updates to Sponsor / Client • Support contract negotiation with study sites, investigator payments, and site-payment tracking • Manage ISF and TMF for assigned study sites in accordance with SOPs or study-specific Monitoring Plans • Identify site issues, implement corrective actions, or escalate as appropriate • Liaise with Clinical Data Management for data-cleaning activities • Assist in preparing and coordinating investigator and client meetings and attend meetings as necessary

🎯 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 Associate's Degree, or 3-year Nursing Diploma with at least 2 years of 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 • Knowledge of the drug development process • Knowledge of International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) • Knowledge of relevant regulations and Standard Operating Procedures (SOPs) • Ability to conduct and complete pre-study, site initiation, interim monitoring, and close-out visits • Ability to manage study site activities and regulatory documentation • Ability to manage Investigational Site Files (ISF) and Trial Master Files (TMF) • Ability to conduct remote monitoring • Ability to utilize systems and reports for subject status, CRF retrieval / source document review, regulatory documents, and investigational product tracking

🏖️ Benefits

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