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Summary of the position:
The Clinical Research Associate (CRA) monitors clinical study site activities 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. Maybe 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. Contributes to the review of sponsor/client’s and/or FHI Clinical’s systems and procedures as appropriate.
· Assists in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation.
· Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines (may be done with Lead CRA/assessor/supervisor as part of assessment period).
· Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites.
· Conducts site assessment, initiation, routine, and close-out monitoring visits (may be done with Lead CRA/assessor/supervisor as part of assessment period).
· Completes accurate monitoring visit reports.
· Develops training materials and conducts training for study implementation based on company policies and SOPs.
· Contributes to the development of and implements protocols and informed consents for research studies.
· Provides guidance on any protocol related issues.
· Manages budget for task assigned are completed as per expectation
· Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
· May serve as a liaison with internal and external partners to ensure effective collaboration efforts.
· Oversees planning of meetings, site visits, and drafting necessary documents.
· Ensures compliance with government regulations when /if contributing to protocols, analysis plans, reports, and manuscripts.
· Provides input with questionnaire development, analysis, study design, and material management.
Knowledge, skills, and abilities:
· Exceptional attention to detail.
· Effective clinical monitoring skills, including remote monitoring.
· Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
· Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.
· Effective organizational and time management skills.
· Effective interpersonal skills.
· Proven flexibility and adaptability.
· Ability to work in a team or independently as required.
Education: Bachelor’s Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field
Preferred Job-related Experience: 3 – 5 years of previous clinical research experience with 2 years of on-site monitoring experience. Proficiency in Microsoft Office, spreadsheet software and other technology required. Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
Additional Eligibility Qualifications: 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 handheld devices.
Preferences: Must be able to read, write and speak fluent English. Master’s degree or its international equivalent preferred. Related prior work experience preferred.
· Typical office environment.
· Ability to sit and stand for extended periods of time; ability to lift5-50 lbs.
Expected travel time is greater than 25% for this position. (default is less than 10%)
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting 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.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.