Clinical Research Associate

This is a fully remote position, open to applicants in Saudi Arabia.

📋 Description

• Oversee project activities related to monitoring Phase I through Phase IV clinical research and Real World Evidence studies.

• Act as the primary CTI liaison for designated study sites.

• Execute pre-study assessments, site initiation, ongoing monitoring, and close-out visits.

• Fulfill site visit obligations with high quality and within the timelines specified in the Monitoring Plan.

• Assist in study start-up tasks, feasibility assessments, pre-study preparations, and site selection.

• Gather, review, and track essential and regulatory documentation.

• Engage in necessary general and study-specific training sessions.

• Participate in meetings with investigators, clients, and project teams.

• Develop and implement strategies for subject enrollment.

• Ensure the proper storage, distribution, and accountability of investigational products and trial-related materials.

• Carry out site management tasks and continuously provide status updates to the Clinical Project Manager.

• Conduct remote monitoring in accordance with study-specific Monitoring Plans.

• Monitor subject status, manage CRF retrieval/source document review, regulatory documents, and investigational product tracking.

• Contribute to project-specific initiatives as a member of the Project Team.

• Assist in the development of CRFs and other study-related documents.

• Aid in the translation, customization, and review of patient information sheets, informed consent documents, protocol summaries, and additional study documents.

• Support submissions and follow-ups with Ethics Committees, Regulatory Authorities, Competent Authorities, or Institutional Administration Boards as part of the Regulatory Affairs Study Start-up Team.

• Provide regular updates to the Sponsor/Client.

• Assist in negotiating contracts with study sites, manage investigator payments, and track site payments.

• Manage Investigational Site Files (ISF) and Trial Master Files (TMF) for assigned study sites in accordance with SOPs or study-specific Monitoring Plans.

• Identify site-related issues, implement corrective actions, or escalate matters as necessary.

• Collaborate with Clinical Data Management for data-cleaning efforts.

• Assist in organizing and coordinating investigator and client meetings, attending as needed.

⛳️ Requirements

• A minimum of 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.

• A Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science.

• An RN with an Associate's Degree, or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources.

• Prior experience in conducting clinical research studies within a hospital environment, pharmaceutical company, or CRO.

• Understanding of the drug development process.

• Familiarity with International Council for Harmonisation (ICH) and Good Clinical Practice (GCP).

• Knowledge of relevant regulations and Standard Operating Procedures (SOPs).

• Capability to conduct and complete pre-study assessments, site initiation, ongoing monitoring, and close-out visits.

• Proficiency in managing study site activities and regulatory documentation.

• Ability to manage Investigational Site Files (ISF) and Trial Master Files (TMF).

• Competence in conducting remote monitoring.

• Proficient in utilizing systems and reports for tracking subject status, CRF retrieval/source document review, regulatory documents, and investigational product tracking.

🏝️ Benefits

• A structured mentoring program and leadership courses.

• Continuous education and training opportunities.

• Tuition reimbursement offered.

• A dedicated training department.

• An award-winning company culture.

• Support for work-life balance.

• Comprehensive health benefits.

• Vacation packages available.

• Opportunities for hybrid work-from-home arrangements.

• Paid parental leave.

• Participation in the CTI Cares program.