The Ideal Candidate:
- Team Player
- Detail Oriented
- Problem Solver
- Analytical
What You'll Do:
- 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.
What You'll Need:
- Approximately 1+ years of on-site and remote monitoring experience; The level/title will be determined as part of the interview process
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Clinical background preferred
- Broad range of therapeutic experience
- High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget
- Superior written and verbal communication skills
- Computer literacy, including proficiency in MS Office and use of EDC systems
- Willingness to travel up to 80%
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any stage of recruitment
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What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.





