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Senior Clinical Research Associate

Company: Joule
Location: Miami
Posted on: January 28, 2023

Job Description:

Senior Clinical Research Associate - Regional Location: Miami, FL Type: Full time Start Date: ASAP Are you an experienced Clinical Research Associate thats looking for lower, regional travel and a good work/life balance? Do you value a healthy, and engaging work environment? This is an excellent opportunity to check off all of the above! You are working for a sponsor, in a therapeutically aligned model supporting Endocrinology studies, conducting remote and onsite monitoring of regional sites in a risk-based monitoring model. Plus - NO DOS metrics! Must haves: Educational requirement: BA/BS Years of experience: 3+ years of CRA (monitoring experience) Industry experience: 5+ years of clinical research industry experience Diabetes experience is a nice to have Remote Monitoring Experience Risk Based Monitoring Job Description: KEY AREAS OF RESPONSIBILITY Site Management Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout Ensure collection of high quality data, timely adverse event reporting, subject protection and compliance to the protocol Adherence to ICH-GCP, regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines. Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables. Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team Identify potential risks and proactively take action to prevent or mitigate Participates in Sponsor and Regulatory audits in Canada; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH-GCP. Other: Adheres to Company policies, procedures ,vision and fundamentals Acts as back up to the other monitors during absences, as requested Performs other tasks as assigned by management WORKING CONDITIONS Works from a home office environment at least one day a week Works at hospitals, medical clinics three to four times a week May be required to drive, fly or take train to location to perform duties of the job Up to 70% travel required PDN-9815c4dc-6312-492f-aa37-c8e96d510a35

Keywords: Joule, Miami , Senior Clinical Research Associate, Other , Miami, Florida

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