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Company name : Actalent
Location : Princeton, NJ 08540
Position : Field Clinical Research Associate
IMMEDIATE NEED for Field CRA position to join to join medical device company specializing in diagnostics products!
Working with a moderate level of remote guidance and direction, is accountable for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials for St. Jude Medical.
Ensures compliance to the study protocol, and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, Good Clinical Practices, applicable regulatory standards, and SJM Standard Operating Procedures.
Able to solve a range of straightforward problems and analyze possible solutions using standard procedures.
Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing adverse events and protocol deviations. Maintains accurate, detailed and complete records of monitoring visits.
In consultation with the assigned Field Clinical Engineer or designee and/or appropriate in-house personnel, coordinates the initiation of the clinical site.
Work requires the application of theoretical principles and creative/analytical techniques.
Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Stays abreast of and consults on technical advancements.
Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues.
Exercises judgment in planning and organizing work; monitors performance and reports status.
Additional Skills & Qualifications:
Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include, but is not limited to:
Reviewing data and source documentation from investigational sites for accuracy and completeness
Ensuring adverse events and protocol deviations are reported in an efficient manner
Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence
Coordinates with study teams, field clinical engineers or designee to:
Enroll sites into new and ongoing clinical studies
Quick Access to Benefits: Medical, Vision, Dental, 401(k)
Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors. We reserve the right
to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
Medical, dental & vision
Insurance (Basic/Supplemental Life & AD&D)
Short and long-term disability
Health & Dependent Care Spending Accounts (HSA & DCFSA)
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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