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Clinical Research Associate

IMARC Research, Inc.

Cleveland, Ohio
  • Healthcare
  • Monitoring
IMARC Research, Inc.
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  • Research Salary

Job Details

The Clinical Research Associate (CRA) from IMARC Research, Inc. will work with a sponsoring company or CRO in the monitoring of device, biologic, and pharmaceutical trials with an emphasis placed on ensuring the highest ethical and clinical standards.

  • Must be willing to relocate to Cleveland, OH or Minneapolis, MN area.

The CRA will monitor clinical research sites in accordance with FDA Regulations, GCP compliance, company SOPs, and client guidelines.

Monitoring responsibilities include: Conducting pre-study, initiation, routine (as needed to ensure protocol compliance), and close-out visits; training study coordinators/investigators on protocol including study procedures, CRF completion, enrollment, and informed consent; working with staff at study sites to resolve data discrepancies; obtaining/reviewing/processing of regulatory and administrative documents from investigative sites; maintaining investigational product accountability; monitoring IRB requirements; and reporting findings from visits.

  • Travel is approximately 50 - 60% to investigative sites and meetings.
  • Travel to international sites may be required.

Knowledge, Skills, and Abilities:

  • At least 18-months previous experience as a CRA
  • RN or BS/MS in a health-related science area
  • Engineering background considered
  • Knowledge of medical terminology
  • Strong knowledge of US federal regulations related to clinical research studies, ICH Guidelines and GCP
  • Excellent organizational and communication skills
  • Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of Internet
  • Time management skills and problem solving abilities
  • Ability to work independently and with teams
  • Excellent writing skills Ability to present self in a highly professional manner in all settings

Salary commensurate with experience.

Travel: 50%-60%.

About IMARC Research: IMARC assists the clinical research community in the pursuit of FDA and worldwide approvals. Our effectiveness is built on preparing, educating, complementing and guiding site teams from Day 1 - to control the complex management of trials via cost-effective monitoring, auditing and training services - which results in the support, proof and assurance they seek to overcome chaos caused by complexity while achieving compliance through consistency. Providing committed, competent and confident consultation is how IMARC sets the highest standards for site outcomes and study partnerships. We at IMARC Research Inc. are committed to helping our employees reach their full potential by establishing a working environment conducive to learning and growth. We aim to provide our employees with foundational support, empowering them to make decisions individually and collectively. We are committed to diversity in the workplace, where trust, respect, and individual talents come together to create positive results.

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