Overview

We are seeking a Clinical Research Associate / CRA for a Fortune 500 medical device company to join our team immediately.
Clinical Research Associate / CRA Responsibilities:

  • Clinical Research Associate complies with all policies, established procedures, regulations and Good Clinical Practice (GCP)
  • CRA 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
  • CRA prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions
  • Clinical Research Associate prepares clinical protocol, clinical brochure, case report forms, informed consents, and other
  • CRA identifies and qualifies clinical investigators and clinical sites
  • CRA initiates payments to clinical sites
  • Clinical Research Associate obtains and reviews all required essential documents necessary for study initiation
  • Clinical Research Associate collaborates with Statistical Support with the collection and statistical analyses of clinical data
  • CRA monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines
  • Clinical Research Associate assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility
  • Clinical Research Associate conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports
  • CRA maintains accurate and timely sponsor/site correspondence and communication
  • CRA reviews data, prepares, and presents clinical data reviews and data summaries
  • Clinical Research Associate responds to audits and data queries
  • Clinical Research Associate prepares and presents project progress reports to keep management and team informed
  • CRA prepares the clinical sections of regulatory submissions and international registration packages
  • CRA functions independently in the field and interacts with all levels of medical and scientific professionals

Requirements:

  • 3-5 years of experience of clinical monitoring of devices for regulatory submission
  • Good working knowledge of FDA regulations and GCP is required
  • Experience as a research coordinator is acceptable, if experience is on studies for regulatory submissions
  • CRA must work independently, communicate and coordinate well with others on study and projects teams
  • IVD experience is highly preferred
  • Travel required could be 20 – 40%
  • Bachelor’s degree
  • Excellent communication (oral and written), organizational, and problem-solving skills
  • Proficiency with Microsoft Office including Excel, Word, Outlook and PowerPoint
  • High energy individual able to effectively multi-task and strive in a dynamic environment
  • Strong attention to details

Benefits:
Once you have been a contract employee of Medix for 30 days, you become eligible for our Benefits Program. Should you elect to enroll, there are three levels of medical coverage to choose from, supplemental dental plans and term plans as well as the option to enroll your spouse and/or children. You can select the best combination that best suits your needs.

As a contract employee with Medix, you can choose to enroll in our Benefits Program during your eligibility period and enjoy:

401(k) Retirement Plan
Paid time off benefits available
A limited benefit medical plan with the American Worker
Doctor visits with inexpensive co-pay
Limited Outpatient Care
Limited Accident Coverage
Prescription Programs
Dental Plan
Vision Discount Program
Term Life Insurance Plans
Medix is dedicated to positively impacting lives every day!
This year’s recipient of the Business Ledger’s “Entrepreneurial Excellence Growth Award”
Join our network of talented professionals!
Compensation: Dependent upon experience
Apply Today!

Job Requirements:
3-5 years of experience of clinical monitoring of devices for regulatory submission Good working knowledge of FDA regulations and GCP is required Experience as a research coordinator is acceptable, if experience is on studies for regulatory submissions CRA must work independently, communicate and coordinate well with others on study and projects teams IVD experience is highly preferred Travel required could be 20 – 40% Bachelor’s degree Excellent communication (oral and written), organizational, and problem-solving skills Proficiency with Microsoft Office including Excel, Word, Outlook and PowerPoint High energy individual able to effectively multi-task and strive in a dynamic environment Strong attention to detailsTracking

To Apply: https://www.jobg8.com/Traffic.aspx?vHgq76jj36%2bl1MnBtycwjQv