[Remote] Senior Clinical Research Associate (Cell & Gene Therapy)

Note: The job is a remote job and is open to candidates in USA. WEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. They are seeking a Senior Clinical Research Associate to oversee clinical monitoring and site management, ensuring compliance with regulatory requirements and building strong relationships with sponsors and sites.ResponsibilitiesContribute 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 selectionPlanned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirementsBuild strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulationsVerify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-readyReview IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actionsManage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrenceTrack and close action items within study or company timelines; maintain clear oversight of monitoring deliverablesSupport 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 escalationsSkillsBachelor'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 appropriateCell and Gene Therapy Experience RequiredBenefitsMedical, 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 leaveCompany OverviewWEP Clinical is a specialist pharma services company that works with drug developers. It was founded in 2008, and is headquartered in Morrisville, North Carolina, USA, with a workforce of 201-500 employees. Its website is http://www.wepclinical.com.