Senior Clinical Research Associate

Company: Adverum Biotechnologies, Inc.
Location: Redwood City
Posted on: June 11, 2021

Job Description:

The Senior Clinical Research Associate is a critical within the clinical team at Adverum that works on-site in the Redwood City office. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. The Sr. CRA will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirement, Good Clinical Practice (GCP) guidelines and company SOPs.

What you'll do:Supports CTM and/or Study Director and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollments, safety, data management, etc.) to accurately coordinate clinical study activitiesLeads or participates in vendor management activitiesAssists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documentsIndependently manages the study start up activities for multi-center, US, and/or global based studiesProvides monitoring oversight by reviewing monitoring schedules, metrics, and reportsDevelop collaborative partnership with clinical sites to ensure that all clinical sites adherence to protocol, trained on study procedures and complies to all applicable GCP/ICH guidelines, regulations statutes and SOPsPerforms in-house routine data listing reviewAssists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirementsMentors and coach junior staff new to Clinical Research (e.g. Clinical Trial Assistant)Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documentsPerforms monitoring visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs to assess the sites' and CRA's overall performance, as neededPerforms other duties and assignments as required for overall success of the projects. Duties my change based on the status of clinical programs and ongoing needed of the organizationAbout you:Working knowledge of ICH/GCP and FDA guidelinesEffective verbal and written communication skillsAttention to detail and organizational skillsAbility to "roll up your sleeves" and individually contribute results in a smaller organization to supports other assigned dutiesOphthalmology experience preferred but not requiredProficiency in MS Word, Excel and PowerPointAbility to travel up to 20%BS/BA, RN, or equivalent with at least 4 years of clinical trial management and vendor management experience/ clinical trial monitoring

Keywords: Adverum Biotechnologies, Inc., Redwood City , Senior Clinical Research Associate, Other , Redwood City, California