Senior Clinical Research Associate – Client Dedicated

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

📋 Description

• Oversee and coordinate all elements of clinical monitoring and site management.

• Execute on-site or remote visits to evaluate compliance with protocols and regulations while managing necessary documentation.

• Administer procedures and guidelines from various sponsors and monitoring environments.

• Ensure adherence to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs throughout trials.

• Maintain audit readiness and cultivate collaborative relationships with investigational sites and client personnel.

• Assist in setting up CRO operations and secure required licenses in the region.

• Provide guidance to study teams regarding feasibility, submissions, contract negotiations, and startup processes.

• Tailor monitoring plans, operational procedures, and tools to align with local regulations.

• Work alongside cross-functional teams to execute study plans and address challenges.

• Monitor investigator sites utilizing risk-based monitoring, root cause analysis, critical thinking, and problem-solving techniques.

• Ensure data integrity through SDR, SDV, and CRF evaluations.

• Review investigational product inventory and documentation.

• Record observations in reports and letters, escalating deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Take part in investigator payments and meetings.

• Identify and initiate engagement with qualified investigative sites.

• Manage trial closeout processes, retrieval of trial materials, and completion of essential documentation.

• Mentor new team members and support project publications, tools, and training initiatives.

• Identify opportunities for process improvements and disseminate solutions.

• Provide trial status tracking and progress updates to the Clinical Lead.

• Update the CTMS and conduct necessary quality-control checks.

• Facilitate communication between sites, the client organization, and the project team.

• Address inquiries from company, client, and regulatory audits and inspections.

• Complete administrative responsibilities such as expense reporting and timesheet submission.

⛳️ Requirements

• Bachelor's degree in a life science-related discipline, or Registered Nursing certification, or an equivalent relevant formal academic/vocational qualification.

• At least 5 years of experience in a clinical research monitor/CRA role.

• In-depth understanding of ICH-GCP guidelines and regulatory requirements.

• Excellent analytical skills and meticulous attention to detail.

• Exceptional communication and organizational abilities.

• Capability to work both independently and collaboratively.

• Valid driver's license is required.

• Proficiency in both Arabic and English.

🏝️ Benefits

• Fully remote work setup

• Chance to contribute to innovative research and support scientific progress

• Collaborative environment with a global team

• Emphasis on diverse perspectives and inclusion

• Reasonable accommodations for individuals with disabilities

• Commitment to equal employment opportunity