28 oct
|
7050 INC Research Clinical Services Mexico Limited, S.A. de
|
La Pampa
28 oct
7050 INC Research Clinical Services Mexico Limited, S.A. de
La Pampa
Worldwide Clinical Trials is seeking a Senior Clinical Research Associate to lead site management activities across a geographice project objectives, deliverables and timelines are met.Must be able to quickly adapt to changing priorities to achieve goals / targets.May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.May provide direct supervision, training and/or mentorship to more junior level CRAs.Performs training and sign off visits for junior CRA staff, as assigned.May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.This could include participation in business development proposals and/or defense meetings.For Real World Late Phase (RWLP), the Sr.
CRA II will use the business card title of Sr.Site Management Associate II.Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out.Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection.As required, collaborate and build relationship with Sponsor and other affiliates,
medical science liaisons and local country staff.The SMA II may be requested to train junior staff.Identify and communicate out of scope activities to Lead CRA/Project Manager.Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.Identify operational efficiencies and process improvements.Develop study and country level informed consent forms.Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared.Participate in bid defense meetings.Provide input into Requests for Proposals (RFPs), scope and budgeting.Develop site management strategy.Participate in Case Report Form design and edit check development.QualificationsBachelor's degree or RN in a related field or equivalent combination of education, training and experience.Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.Must demonstrate good computer skills and be able to embrace new technologies.Excellent communication, presentation and interpersonal skills.Moderate level of critical thinking skills expected.Ability to manage required travel of up to 75% on a regular basis.Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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📌 Lead Clinical Trial Site Manager (La Pampa)
🏢 7050 INC Research Clinical Services Mexico Limited, S.A. de
📍 La Pampa