CRA II

CTI Clinical Trial and Consulting Services; Riyadh Region; On-site; SAR 120,000 - 180,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a capable clinical trial monitor in Saudi Arabia to oversee monitoring activities from Phase I to IV and Real World Evidence studies. You will develop knowledge of drug development, ICH GCP, and regulatory guidelines while managing study site activities in line with SOPs.

Responsibilities include conducting site visits, collecting and tracking regulatory documents, supporting start-up activities, and coordinating with sponsors and project

Qualifications

• Minimum 1 year of clinical trial monitoring experience or equivalent as determined by CTI Management and HR.
• Bachelor's degree or higher in allied health field or RN with relevant qualifications; nursing diploma with experience acceptable.
• Experience in hospital, CRO, or pharmaceutical settings handling clinical research activities.

Responsibilities

• Serve as main CTI contact for assigned study sites and manage monitoring visits (PSV, SIV, IMV, COV).
• Complete site visit deliverables within Monitoring Plan timelines, adhering to SOPs and ICH GCP.
• Assist with study start-up, including feasibility, pre-study activities and site selection.
• Collect, review, and track essential regulatory documents and training.
• Participate in investigator, client and project team meetings; support CRF development as needed.
• Ensure proper storage, dispensation and accountability of Investigational Product and trial materials.
• Liaise with Data Management for data cleaning and site status updates to the Clinical Project Manager.
• Support regulatory affairs, ethics submissions, and site payments; manage ISF and TMF per SOPs.

Skills

Clinical trial monitoring

Regulatory compliance knowledge

Study coordination

Education

Bachelor's degree or higher in allied health field such as nursing, pharmacy, or health/science

Job description

About The Job

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

About The Job

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

What You'll Do

• Serve as main CTI contact for assigned study sites
• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV])

and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP

• Assist with study start-up activities, including feasibility, pre-study activities and site selection
• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings
• Create and implement subject enrollment strategies for assigned study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team
• May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
• Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client
• Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalation 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

Required Education And Experience

• 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 allied health field such as nursing, pharmacy, or health / natural science, or RN with 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 in conducting clinical research studies in hospital setting, pharmaceutical company or CRO

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.