Senior Clinical Research Associate
Company: Joule
Location: Miami
Posted on: January 28, 2023
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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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