21 Jobs in Miami, FL
System One is Hiring a Senior Clinical Research Associate Near Miami, FL
Type: Full time salaried direct with Joule - health benefits, paid time off and 401K offered Start Date: ASAP
Are you an experienced Clinical Research Associate that's 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.
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 |
#M3
Job Summary
Contractor
Business Services
$66k-87k (estimate)
05/25/2024
08/21/2024
healthsystemone.com
MIAMI, FL
25 - 50
Private
JOSEPH BRUCE
$10M - $50M
Business Services
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The job skills required for Senior Clinical Research Associate include Clinical Research, SOP, Accountability, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Clinical Research Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Clinical Research Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Clinical Research Associate positions, which can be used as a reference in future career path planning. As a Senior Clinical Research Associate, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Clinical Research Associate. You can explore the career advancement for a Senior Clinical Research Associate below and select your interested title to get hiring information.
