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Sr.CRA in KSA - Single Sponsor - CKD

Sr.CRA in KSA - Single Sponsor - CKD

Syneos Health, Inc.WorkFromHome, Saudi Arabia
19 منذ ساعات
الوصف الوظيفي

Updated : October 24, 2025

Location : SAU-Remote

Job ID :

Sr. Clinical Research Associate – KSA (Single Sponsor – CKD)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization building actionable insights to accelerate customer success. Our Clinical Development model places the customer and the patient at the center of everything we do.

Job Responsibilities

  • Perform site qualification, initiation, interim monitoring, site management, and close‑out visits (on‑site or remotely), ensuring regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practices (GPP) compliance.
  • Verify informed consent processes, protect confidentiality, and assess factors affecting subject safety and data integrity.
  • Follow Clinical Monitoring / Site Management Plan (CMP / SMP) : assess site processes, conduct source document reviews, verify CRF data accuracy, resolve queries, and ensure electronic data capture compliance.
  • Conduct investigational product (IP) inventory, reconciliation, storage, and security reviews; ensure proper dispensing and administration.
  • Review Investigator Site File (ISF) accuracy, reconcile with Trial Master File (TMF), and ensure archiving per local guidelines.
  • Document activities via letters, reports, and communication logs; support recruitment, retention, and awareness strategies; enter data into tracking systems.
  • Manage project scope, budgets, and timelines; adapt to changing priorities and achieve goals.
  • Serve as primary liaison with study site personnel and coordinate with Central Monitoring Associates; train and ensure compliance of site staff.
  • Prepare for and attend investigator and sponsor meetings; lead global monitoring / project staff meetings and clinical training sessions.
  • Provide audit‑readiness guidance and support audit preparation.
  • Provide supervision, training, and mentorship to junior CRAs; support business development proposals and defense meetings.
  • For Real World Late Phase (RWLP) : support site activities through the study lifecycle, conduct chart abstraction, collaborate with sponsors, train juniors, identify out‑of‑scope activities, propose sites, identify efficiencies, develop informed consent forms, collaborate with regulatory teams, participate in bid defense meetings, prepare RFPs, develop site management strategy, and contribute to CRF design.

Qualifications

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice / ICH Guidelines and applicable regulatory requirements.
  • Proficient computer skills and adaptability to new technologies.
  • Excellent communication, presentation, and interpersonal skills; moderate critical thinking ability.
  • Capacity to travel up to 75% regularly.
  • We are always excited to connect with great talent. This posting is intended for an upcoming opportunity rather than a live role. By expressing your interest, you will be added to our talent pipeline and considered should the role become available.

    Get to know Syneos Health : Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

    Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you have a disability requiring reasonable accommodation, please contact us at

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