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.
If you're interested in a career with IMARC, please send your resume to email@example.com.