Clinical Research Associate / Senior CRA - Client Dedicated (FSP)

About the Role

Join a global leader in clinical research and contribute to advancing pharmaceutical innovation by supporting top pharmaceutical and biotech companies. As a Clinical Research Associate (CRA) at Level II, you will oversee and coordinate all clinical monitoring and site management functions either remotely or onsite. This position involves ensuring adherence to clinical protocols, regulatory requirements, and sponsor-specific procedures within various monitoring environments such as FSO, FSP, and Government projects. You will be an expert in site processes, guaranteeing trials comply with approved protocols, ICH-GCP standards, and regulatory frameworks to protect patient safety and data quality.

Key Responsibilities

• Conduct site monitoring using risk-based strategies, employing root cause analysis and critical thinking to detect and rectify site process failures, thereby minimizing risk.
• Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) evaluations both during onsite and remote visits to assure data accuracy.
• Manage investigational product inventory checks through physical and record audits.
• Document findings promptly following company standards and escalate clinical management regarding deficiencies, continuing to follow up until resolution.
• Maintain contact between visits with investigative sites to verify ongoing protocol adherence and timely data reporting.
• Assist in investigator meetings, identify potential clinical sites, initiate clinical trial sites in accordance with procedures, and conduct trial closeouts including material retrieval.
• Ensure essential regulatory documents are complete and compliant via thorough file reviews per project needs.
• Provide progress updates and maintain study tracking systems as per project conventions.
• Facilitate effective communication among investigative sites, clients, and project teams.
• Respond to audit and inspection requirements by company, clients, and regulators.
• Complete administrative responsibilities such as expense reporting and timesheets punctually.
• Support project teams with preparation of publications, tools, and share improvement suggestions.
• Participate in continuous process improvement initiatives when required.

Qualifications and Experience

• Bachelor’s degree in life sciences or equivalent, or Registered Nurse certification with pertinent academic or vocational credentials.
• At least 1 year of clinical research monitoring experience or completion of a recognized clinical development fellowship.
• Valid driver's license where necessary.
• Equivalency through combined education, training, and experience may be accepted.

Skills and Abilities

• Strong clinical monitoring expertise.
• Familiarity with medical terminology and therapeutic areas relevant to trials.
• In-depth knowledge of ICH-GCP guidelines and regulatory standards.
• Excellent critical thinking, root cause analysis and problem-solving capabilities.
• Experience managing risk-based monitoring activities.
• Proficient communication skills, both written and oral, tailored for medical professionals.
• Keen customer focus with excellent listening and detail orientation.
• Effective organizational and time management skills.
• Ability to work well both independently and collaboratively.
• Good computer proficiency including Microsoft Office and other relevant clinical software.
• Fluency in Arabic and competent English language skills.
• Presentation skills to support trainings and meetings.

Working Environment

• Work setting includes office, laboratory, clinical, and home office locations with use of computer and electrical office equipment.
• Frequent travel required to clinical sites, approximately 60-80%, occasionally including extended overnight trips.
• Exposure to biological fluids with potential risk of infectious diseases; personal protective equipment such as gloves, eyewear, and garments is mandatory.
• Rare exposure to varying or extreme temperature conditions.