Senior Clinical Research Associate

Are you looking for an exciting and fulfilling new position? 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 organization 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.Cell and Gene Therapy Experience RequiredThe Ideal Candidate:LeaderDetail OrientedProblem SolverAdaptableWhat 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 improvementsBroad therapeutic exposure across multiple study types and indicationsStrong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocolsAdvanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelinesExcellent written and verbal communication; confident stakeholder engagementSolid understanding of medical/therapeutic areas and medical terminologyProven ability to train, coach, and mentor clinical research staffProficient with MS Office and EDC systems; willing to travel up to 80%Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriateLocation eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia. What We Offer:Medical, dental, and vision insuranceFSA, HSAVoluntary Critical Illness, Hospital Indemnity, and Accident InsuranceGroup short-term and long-term disability insuranceGroup Life Insurance401K safe harbor plan and company matchPaid vacation, holiday, sick and volunteer timePaid maternity & paternity leaveWhat 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 personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.We're Committed