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Clinical Trial Assistant/Senior Clinical Trial Assistant

Company: Adverum Biotechnologies, Inc.
Location: Redwood City
Posted on: May 3, 2021

Job Description:

This position has responsibility to support the conduct of clinical trials, handling administrative aspects

of clinical trial execution and tracking the progress of clinical trials. The position coordinates and tracks

all study documentation including regulatory documents, study drug documents and clinical trial

payments.

What you'll do:Provide support in project-specific tasks and the overall management of clinical trials to the Clinical Operations Department.Assist in the coordination, organization of study management team meetings, sponsor and site, vendor teleconferences, including writing and distributing meeting minutes and agendas.Assist with the planning and logistics of formal meetings including investigator meetings.Develops study tools and guidelines to be utilized by study sitesUnderstands study timelines and manages sites and vendors to meet timelinesContributes to writing informed consent templates, protocol and/or other documents. Applies knowledge of regulatory requirements/SOPs to documentsCoordinates (as needed) and reviews regulatory documents from study sites; ensures completeness and accuracyEnsures study records are auditable both at investigational sites and in-houseAssists study manager with the vendor invoice review and payment processCommunicates status of trial to manager and teamPartners with team members and other functional areas within Adverum such as Regulatory, QA, Legal, CMCConducts co-monitoring and monitoring site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conductHelp to develop and write SOPs for the Clinical Operations DepartmentAssist in the maintenance of central files including maintaining version and quality control of study documents submitted, assist in the file review of site clinical regulatory documentation to confirm completeness/track dates and reconciliation for audits, and preparing study files for archival.Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management.Order and maintain ancillary clinical study supplies required for conduct of clinical trials, including copying, printing study documents, reference binders, and arrange shipping, tracking, accordingly.Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements.Assist with processing invoices from vendors Initiate request for investigator, site and vendor payments.Enters and maintains study information in Clinical Trial Management System.The Sr CTA may assist with vendor oversight and management, help identify issues in a timely manner and escalates to management as appropriate.Conducts critical review and reconciliation of essential documents in TMF and independently manages TMF filing and management tasks.Ensure timely completion of study tasks and update trial trackers on an on-going basis.Audit of TMF.Other duties as assigned.About you:Bachelor's degree preferred. Preference in a health care or scientific discipline.1-4 years' experience within clinical research or related experience in a pharmaceutical, biotechnology, CRO, healthcare setting, OR 6-8+ years' experience within a Clinical Trials Assistant roleStrong attention to detail and excellent organization skills.Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment.Excellent verbal, written communication and presentation skills are required.Experience using Office 365 (Word, Excel, Power Point) applications and SharepointExperience with IXRS and EDC systems a plus.Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures.Ability to develop tools and processes that increase measured efficiencies of the project.Experience in gene therapy and/or rare disease indications preferred.

Keywords: Adverum Biotechnologies, Inc., Redwood City , Clinical Trial Assistant/Senior Clinical Trial Assistant, Other , Redwood City, California

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