Address
Form of work
SalaryAdecco is currently assisting an American supplier of scientific instrumentation, reagents and consumables, and software services in recruiting for an Expert Clinical Research Associate role in Quail Heights, FL.
The Clinical Research Associate (CRA) is responsible for supporting clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval. This position is part of the Clinical Affairs Department for the Clinical Decision Support business unit and is fully remote.
Schedule: 8am – 5pm Mon-Fri
Pay Rate: The wage for this position is between $50 and $52.10. Hourly wage may depend upon experience, education, geographic location and other factors.
Key Objectives of the role:
Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
Onsite and/or remote monitoring of data and overseeing corrective actions.
Drive schedule deliverables to meet the overall study timelines.
Develop and drive centralized processes to optimize instrument device data, reconciliation of instrument data to sample list, identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures.
Partner with data management team to effectively operate within data management plan and data management procedures including the Laboratory Information Data Management System (LIDMS).
Support clinical team which may include activities related to budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, vendor support activities.
Adherence of PHI protection and GCP
Minimum Qualifications:
Bachelor's degree or equivalent in the life sciences, with 4+ years' work experience in vitro diagnostics (IVD), Medical Device, or Pharmaceutical research; 2+ years' experience with Master's degree, or 1+ years with Doctoral degree.
Demonstrated agility with processes and details, ability to apply critically-thinking, analyze data (using analytical tools), and solve complex problems.
Ability to work independently and effectively under a fast-paced and changing environment
Proficiency Microsoft Office Excel and Outlook
Able to travel 10% or as needed
Preferred Qualifications:
Real-world data
Cardiovascular clinical trials
Electronic data capture (EDC) system (Medidata) and eTMF system (Florence)
Clinical research certification (i.e., SOCRA, CCRA, CCRC)
Click on apply now for instant consideration!
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
Pay Details: $50.00 to $52.10 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
