Clinical Research Associate (CRA) - C

Experis

Job Description

Hello,

Experis, a ManpowerGroup company has an exciting contract opportunity for Clinical Research Associate . This position is a 12-month contract for one of our key clients, a global manufacturing company that is engaged in the discovery, development, and manufacturer of medical devices.

Job Title: Clinical Research Associate


Location: Des Plaines, IL


Duration: 12 Months (possibly extension)


Job Descriptions:

  • Complies with all policies, established procedures, regulations, and Good Clinical Practice (GCP).
  • Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge and skills in performing assigned assays or operating instruments.
  • Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
  • Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
  • Identifies and qualifies clinical investigators and clinical sites.
  • Initiates payments to clinical sites.
  • Obtains and reviews all required essential documents necessary for study initiation.
  • Collaborates with Statistical Support with the collection and statistical analyses of clinical data.
  • Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines.
  • Assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.
  • Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.
  • Maintains accurate and timely sponsor/site correspondence and communication.
  • Review's data, prepares, and presents clinical data reviews and data summaries.
  • Responds to audits and data queries.
  • Prepares and presents project progress reports to keep management and team informed.
  • Prepares the clinical sections of regulatory submissions and international registration packages.
  • Functions independently in the field and interacts with all levels of medical and scientific professionals.

Additional Requirements:

  • Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
  • Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups.
  • Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
  • Accountable for the project scope and scheduled completion date.
  • Works under the direction of the Clinical Project Manager

Regards

Kushagra Mohan I
Talent Acquisition Specialist
Experis CORE
414-203-8334, Ext:7165

100 Manpower Place | Milwaukee, WI 53212

Job Requirements

 

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