Job description

Here are the job position details for your review:

Job Title: Clinical Research Associate
Pay Rate: $58 to 63/Hr
Duration: 11 Months
Location: REMOTE with 50% travel (Preference of someone from Mid US to the West coast region - TX, AZ, UT, WA, OR, CO, etc.)

We are looking for a Clinical Research Associate for our in-vitro diagnostics products.

• Aid in the design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, reports, statistical data analysis plans, and associated study data collection forms.
• Supervise study sites and activities to ensure adherence to protocols and terms of the study
• With minimum supervision, completes all activities related to the set-up, initiation, execution, and close-out of in vitro diagnostic device clinical trials including sample collection, timely review, and analysis of data generated.
• Independently schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy, and completeness of clinical data.
• Communicates with study investigators via phone, fax, email, and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
• Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure the integrity of the database.
• Responsible for monitoring and preliminary analysis of test data. Must be capable of assessing precision, accuracy, and identifying trends in data.
• Provides up-to-date clinical study progress reports.
• Negotiates site-specific study budgets initiates and oversees contract origination, compliance approval, and execution.
• Completes the tracking of budgets for studies.
• Remains current with regulatory requirements for in vitro diagnostic products.
• Represents Clinical Affairs on a multifunctional team tasked with preparing responses to regulatory agencies.
• Represents Clinical Affairs on a multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting the results of the clinical studies

Requirements:

• 3 to 5 years of experience as a Clinical Research Associate
• Bachelor's Degree in Life Sciences
• Medical Technologist or Lab Tech experience working with Chemistry/Blood Analyzers
• Knowledge of Chemical Research
• Interpersonal Skills
• Must travel approximately 50%
• Preference of someone from Mid US to the West coast region - TX, AZ, UT, WA, OR, CO, etc.

Job Type: Full-time

Salary: $58.00 - $63.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Willingness to travel:

• 50% (Required)

Work Location: Remote

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