Job Title

Scientific & Clinical Job Details

Clinical Research Associate

Job Code: #713
Job Type: Contract
Salary: $16.00 - $16.50/hour
Job Location: Lincolnshire, IL
Posted 2 days ago

Job Description

Job Title:  Clinical Research Associate

Pay:  $45.00/hour

Position Summary:  Responsible for implementing and monitoring clinical studies of new and modified products. Assists with preparation of clinical protocols, study progress reports and clinical trial reports.

Essential Duties and Responsibilities:

  • Knowledge of regulations and standards affecting products. Complies with all polices, established procedures, and regulations related to clinical research, including 21CFR Parts 50, 56 & 58. 
  • Assists with preparation of clinical protocols, informed consent, clinical trial report, and other required documents for clinical studies.  Assists with responses to regulatory agency questions pertaining to clinical studies.
  • Initiates legal documents including Non-disclosure Agreements and Clinical Trial Agreements. Proposes and negotiates budgets for clinical studies. Initiates and track payments to sites ensuring budget adherence.
  • Assists with obtaining and reviewing all required essential documents necessary for study initiation.
  • Initiates clinical studies and provides investigator and staff training.  Monitors clinical studies, ensuring site compliance with the clinical protocol and GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy and legibility. 
  • Assists Data Management and Statistics with the collection and querying of clinical data and tracking of enrollment at the clinical sites
  • Prepares study updates to keep management informed.

Qualifications:

  • Minimum Bachelor’s Degree in science related field, or equivalent.  Medical Technology background preferred.
  • A minimum of 2 to 3 years of Clinical Research experience
  • Experience working directly with clinical investigators and study sites
  • Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices. 
  • Good foundation in laboratory testing methodologies.
  • Effective verbal and written communication skills
  • Computer literacy to operate standard word processing, spreadsheets, presentation and internet application.
  • Detail oriented with strong prioritization skills.
  • Ability to travel up to 40% of time.
  • Effective time management skills.