WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”
ResponsibilitiesJob Summary: The Senior Clinical Research Associate is a critical position within the Operations team and is assigned as a study lead to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites.
Essential Job Functions:
Participate in and may facilitate cross-functional study teams, liaise with other functional areas to accurately coordinate clinical study activitiesCoordinate clinical study timelines to meet critical milestones; escalate issues that may jeopardize timelines and deliverablesProvide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reportsProvide regular updates of study progression; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issuesParticipate in developing study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverablesImplement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidanceMaintains project timeline, conducts risk assessment/mitigation and contingency planningTracks and reports project enrollment, builds and maintains study trackers, organizes and maintains meetings cross-functionallySupports/assists with oversight and accountability of all third-party vendorsReviews monitoring visit reports; liaise with monitors to understand any trends on quality issues or other site issues to develop solutionsParticipate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study teamWork on study feasibility assessments and selection of countries and sites for study conductCreate and conduct training sessions including investigator meetings and team trainingsProvide oversight and direction to study team members, including vendors, for study deliverablesAll work must adhere to ICH/GCP guidelines and comply with company SOP'sReview/approve vendor/site invoicesMentors junior members of the teamQualifications
Experience / Education:
Minimum of 4 years experience as a Clinical Research Associate in the pharmaceutical/biotech or CRO industryBS in a life science discipline is preferredMust have strong knowledge of ICH/GCP guidelinesComprehensive understanding of the drug development processAdept at managing/functioning within a cross-functional project teamStrong interpersonal, communication and leadership skillsProficient with MS office High level of organizational skills, able to prioritize and manage tasks simultaneouslyAbility to work independently in a matrix environmentFlexibility to accommodate changes in priorities and project needsApproximately 50% to study sites to monitor, co-monitor, train, attend Investigator meetings or conferences(Masters, Bachelors, Associate, High school diploma or equivalent experience)Preferred (Ex. AALAC certifications, SPHR)
Knowledge / Skills / Abilities:
Proficient in oral & written communication skillsProficient in Microsoft (Excel, Word, Outlook)Physical Requirements:
Ability to stand/sit/walk for long periods of time Ability to Lift 10 lbs occasionallyAbility to crouch, bend, twist, and reach
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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