Senior CRA, IoR & Regulatory Experience

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, protocols, and site requirements.

• Assess site and staff performance; communicate critical issues and formulate action plans.

• Verify informed consent processes, maintain subject/patient confidentiality, ensure safety, and address protocol deviations, violations, and pharmacovigilance concerns.

• Evaluate site procedures and perform source document and medical record reviews.

• Validate clinical data entered in CRFs and resolve inquiries within established timelines.

• Assist with electronic data capture and ensure site compliance.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, labeling, import, and return/release as necessary.

• Review and reconcile Investigator Site Files with Trial Master Files and guarantee proper archiving.

• Document monitoring activities, track observations and action items, and assist with recruitment and retention efforts.

• Manage site-level activities and communications to align with project objectives, deliverables, budgets, and timelines.

• Collaborate with study-site personnel to ensure training and compliance for assigned sites and project staff.

• Prepare for and participate in investigator, sponsor, monitoring, project, and clinical training meetings.

• Support audit readiness, audit preparation, and follow-up actions.

• Provide supervision, training, mentorship, and sign-off visits for junior CRAs.

• For RWLP, assist sites throughout the study lifecycle, including chart abstraction, data collection, sponsor and affiliate relationships, site identification, informed-consent form development, regulatory coordination, process improvements, RFPs, bid defenses, budgeting, site-management strategy, CRF design, and edit-check development.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or a combination of education, training, and experience that is equivalent.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Strong knowledge of informed consent, source document review, clinical data analysis, and regulatory compliance.

• Proficient computer skills and openness to adopting new technologies.

• Exceptional communication, presentation, and interpersonal skills.

• Moderate critical thinking abilities.

• Willingness to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• A culture of total self that promotes authenticity and a sense of belonging.

• Commitment to diversity, inclusion, and a feeling of belonging.

• Reasonable accommodations provided when appropriate.