The Role
Lead on-site and remote clinical monitoring to ensure protocol, ICH-GCP, and regulatory compliance. Manage site selection, initiation, routine and close-out visits; verify source data and CRFs; review safety and IP accountability; resolve queries and drive CAPAs; train and mentor CRAs; act as primary monitoring contact for sponsors and project teams.
Summary Generated by Built In
Are you seeking an exciting and fulfilling new opportunity? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Senior Clinical Research Associate (Senior CRA) oversees all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs. They conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready. The Senior CRA builds strong relationships with sponsors and sites, serving as a key point of contact throughout the study. They may also support development of study-specific procedures (e.g., Monitoring Plans) and assist in training or coordinating other CRAs.
The Ideal Candidate:
- Leader
- Detail Oriented
- Problem Solver
- Adaptable
What You'll Do:
- Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans).
- Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection.
- Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements.
- Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations.
- Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready.
- Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions.
- Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence.
- Track and close action items within study or company timelines; maintain clear oversight of monitoring deliverables.
- Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates.
- (Lead CRA, if assigned) Oversee monitoring on complex studies; develop study-specific monitoring documents (e.g., CMP, deviation plan, report templates); finalize visit reports; train/coordinate CRAs; act as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations.
What You'll Need:
- Bachelor’s degree (life sciences, nursing, or related field preferred)
- 5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience)
- Senior CRA levelling: SCRA I (3–5 yrs) – independently manages complex sites; SCRA II (5+ yrs) – oversees complex sites/regions, mentors peers, and drives process improvements
- Broad therapeutic exposure across multiple study types and indications
- Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols
- Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines
- Excellent written and verbal communication; confident stakeholder engagement
- Solid understanding of medical/therapeutic areas and medical terminology
- Proven ability to train, coach, and mentor clinical research staff
- Proficient with MS Office and EDC systems; willing to travel up to 80%
What We Offer:
For international hires employed through an employer-of-record partner, benefits and leave offerings may vary based on local regulations and regional employment practices.
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn life page to learn more about our team events and all that we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
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.
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
#LI-fulltime #LI-remote
Skills Required
- Bachelor's degree (life sciences, nursing, or related field)
- 5-7+ years' experience conducting on-site and remote monitoring visits or equivalent clinical research experience
- Demonstrable knowledge of ICH-GCP, global regulatory requirements, and clinical monitoring SOPs
- Experience performing site feasibility, SIVs, routine monitoring, and close-out visits
- Broad therapeutic exposure across multiple study types and indications
- Proven ability to verify source data, manage CRFs, and maintain audit-ready site documentation
- Experience reviewing IP accountability, safety event documentation, protocol deviations, and implementing CAPAs
- Proven ability to train, coach, and mentor clinical research staff
- Excellent written and verbal communication and strong stakeholder engagement skills
- Proficient with MS Office and EDC systems
- Willingness to travel up to 80%
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The Company
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.
