WEP Clinical

QA Engineer

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities.
• Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements.
• Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Senior Clinical Quality Assurance Associate

Research Analyst

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV).
• Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed.
• Review site-level investigational drug accountability and safety event documentation.
• Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required.
• Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan.
• Manage query resolution.
• Provide mentoring, training, and co-monitoring of junior team members.
• Assist in the development of applicable WEP Clinical Standard Operating Procedures.
• Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs.
• Complete, review, and/or submit monitoring reports and query logs.
• Address protocol or monitoring-related questions received from clinical sites for assigned programs.

Clinical Research Associate

Associate

• Collaborate with Clinical Operations to develop site initiation timelines and ensure adherence to project milestones
• Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions
• Coordinate with contracts and budget teams to ensure timely execution of site agreements
• Assist with the preparation and submission of essential regulatory documents for site activation
• Ensure all documents are approved by ethics committees and IRBs before site activation
• Track progress of regulatory submissions, site contracts, and essential document collection
• Verify site readiness with adequate resources and completed training prior to patient enrolment
• Participate in study kick-off and initiation meetings to align expectations and timelines
• Troubleshoot activation issues and escalate problems to the Project Manager or CRA when needed
• Assist with the setup of study supplies and equipment at the site, including investigational products and lab kits

Site Management Associate

Project Manager

• The Clinical Project Manager at WEP Clinical is responsible for the setup, implementation, and management of clinical trials, ensuring patient safety, data integrity, and high-quality delivery in compliance with applicable regulations.
• This role provides leadership across cross-functional teams, manages client relationships, and is accountable for delivering clinical trials on time, within scope, and within budget.

Clinical Trial Project Manager

• Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs
• Conduct on-site and remote monitoring to ensure protocol adherence
• Maintain essential documentation and keep site and patient data inspection-ready
• Build strong relationships with sponsors and sites
• Serve as a key point of contact throughout the study
• Support development of study-specific procedures (e.g., Monitoring Plans)
• Assist in training or coordinating other CRAs

Senior Clinical Quality Assurance Associate

Clinical Research Associate

Site Management Associate

Clinical Trial Project Manager

Senior Clinical Research Associate, Cell & Gene Therapy