Clinical Research Associates (CRAs)
Company: IMARC Research, Inc.
Posted on: February 15, 2018
CLINICAL RESEARCH ASSOCIATES (CRAS)
The clinical research associate (CRA) from IMARC Research, Inc. will work with a sponsoring company or CRO in the monitoring of pharmaceutical or device trials with an emphasis placed on ensuring the highest ethical and clinical standards.
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 the 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.
Must be willing to relocate to Cleveland, OH or Minneapolis, MN area.
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.
Keywords: IMARC Research, Inc., Minneapolis, Clinical Research Associates (CRAs), Healthcare, Minneapolis, Minnesota
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