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FHI 360 (formerly Family Health International) is a nonprofit human development organization based in North Carolina. FHI 360 serves more than 70 countries and all U.S. states and territories
The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports. May be responsible for multiple projects and must work both independently and in a team environment. Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training. S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory- compliant clinical projects are conducted on time and within budget. Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI360’s systems and procedures as appropriate.
Accountabilities:
Applied Knowledge & Skills:
Problem Solving & Impact:
Supervision Given / Received:
Education:
Bachelor’s Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
Experience:
Technology to be Used:
Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand-held devices.
Travel Requirements:
Greater than 75%
Typical Physical Demands:
Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Disclaimer: Note the Compensation Band that appears on the job description is associated with those jobs assigned to the US Salary Structure and employees that are paid from US payroll.
The Compensation Band for all national local employees aligns to the Compensation Structure based on the Count
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
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