Sr CRA (Saudi Arabia) Riyadh

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 or oversee 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; may include
presentations
* 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 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
* Participate in the development of CRFs and other study related documents
(subject worksheets,

Monitoring Plan, etc.)

* Perform translation, customization, and review of Patient Information sheet
and Informed Consent,

protocol synopsis and other study applicable documents as per required
procedures

* Where applicable, support or oversee 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 and anticipate site issues and implement corrective and preventive
actions or escalate as appropriate
* Liaise with Clinical Data Management for data cleaning activities
* Serve as mentor / trainer for CRAs; may include conducting
training/assessment visitsWhere 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
* Function in the role of Lead CRA for assigned project(s) 

REQUIRED EDUCATION AND EXPERIENCE 

* At least 3 years 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                           

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 [http://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.

Important Note

In light of recent increase in hiring scams, if you’re selected to move onto the
next phase of our hiring process, a member of our team will reach out to you
directly from an @ctifacts.com email address to guide you through our interview
process. Please ensure you are applying for jobs directly on our website
(www.ctifacts.com) or from our verified LinkedIn page.

Please Note

* * We will never communicate with you via Microsoft Teams or text message.
* We will never ask for your bank account information at any point during the
recruitment process.

Responsible for monitoring Phase I-IV clinical research and Real World Evidence studies, ensuring adherence to regulatory guidelines and SOPs. Key duties include conducting site visits, managing essential documents, and serving as the primary contact for assigned study sites.

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