Clinical Research Associate, Client Dedicated – FSP

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

📋 Description

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

• Perform remote or on-site visits to evaluate compliance with protocols and regulations.

• Manage necessary clinical trial documentation along with sponsor and monitoring procedures.

• Ensure adherence to approved protocols, ICH-GCP guidelines, relevant regulations, and standard operating procedures (SOPs).

• Monitor investigative sites utilizing risk-based monitoring techniques, which include root cause analysis, source data review (SDR), source data verification (SDV), and case report form (CRF) assessment.

• Evaluate the inventory and documentation of investigational products.

• Record observations and escalate any deficiencies until resolution is achieved.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Engage in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations for compliance.

• Carry out trial closeouts and retrieve trial materials.

• Ensure completeness of essential documents and conduct on-site file reviews.

• Provide tracking of trial status and progress reports to the Clinical Team Manager.

• Update study systems, such as Clinical Trial Management Systems.

• Facilitate communication among sites, the client company, and the PPD project team.

• Address company, client, and regulatory demands, audits, and inspections.

• Complete expense reports and timesheets.

• Assist with project publications and tools, contributing to process improvement initiatives.

⛳️ Requirements

• Bachelor’s degree in a life sciences-related field, or Registered Nursing certification, or an equivalent relevant formal academic or vocational qualification.

• A minimum of 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Valid driver’s license where applicable.

• Equivalency through appropriate education, training, and/or directly related experience may be taken into account.

• Demonstrated skills in clinical monitoring.

• Knowledge of medical and therapeutic areas along with medical terminology.

• Proficient understanding of ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving capabilities.

• Ability to manage concepts and processes related to Risk-Based Monitoring.

• Effective oral and written communication skills.

• Customer-focused with strong listening skills, attention to detail, and the ability to identify underlying issues.

• Strong organizational and time management abilities.

• Excellent interpersonal skills.

• Adaptability and flexibility.

• Capability to work independently or collaboratively as part of a team.

• Proficient Microsoft Office skills and the ability to learn necessary software.

• Fluency in Arabic and strong command of the English language and grammar.

• Good presentation abilities.

• Willingness to travel frequently, generally 60–80%, including potential extended overnight stays.

• Ability to work in environments with potential exposure to biological fluids and infectious organisms.

• Willingness to use required personal protective equipment.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunity to collaborate with a global team.

• Exposure to cutting-edge technologies and pharmaceutical services.

• Reasonable accommodations for individuals with disabilities.

• Commitment to equal opportunity employment.