Senior Clinical Research Associate – Regional
Location: Remote-based, Southern Georgia / Northern Florida / Eastern Alabama
Type: Full time, long-term salaried contract
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 in a therapeutically aligned model with a single sponsor supporting Endocrinology studies, conducting remote and onsite monitoring of regional sites.
Plus – NO DOS metrics!
Must haves:
Educational requirement: BA/BS
Years of experience: 4+ years of CRA (monitoring experience)
Industry experience: 6+ 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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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