FHI 360 is a global organization that mobilizes research, resources and relationships so people everywhere have access to the opportunities they need to lead full and healthy lives. With collaborations in over 60 countries, we work directly with local leaders to advance social and economic equity, improve health and well-being, respond to humanitarian crises and strengthen community resilience.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
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The Clinical Research Associate II (CRA II) manages clinical study sites and monitors site activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), study protocols, and applicable regulatory requirements.
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.
Essential Functions:
Contributes to the development of routine protocols, informed consents, SOPs, and other appropriate documentation. Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA and/or other regulations, and ICH GCP Guidelines. Ensures timely submission of protocols, informed consents, safety report reports and other regulatory documents for IRBs/IEC approval according to local requirements.
Knowledge, Skills, and Abilities:
- Demonstrated understanding of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and other International Council on Harmonization (ICH) guidelines.
- Good knowledge of concepts, practices, and procedures for conducting clinical research studies.
- Computer skills, including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Exceptional attention to detail.
- Ability to establish and maintain effective working relationships with coworkers, managers, site staff and clients.
- Solid knowledge of software programs used to collect data and track risk-based monitoring parameters.
- Ability to analyze and interpret data, identify errors, and prepare reports.
- Effective clinical monitoring skills, including remote monitoring.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Proven flexibility and adaptability.
- Ability to work in a team or independently as required.
Position Requirements:
Education: Bachelor’s or higher graduate degree (or its international equivalent) in a medical / science-related field is preferred. In lieu of a degree, an equivalent combination of diplomas or certification and relevant work experience is required. Licensed or certified health care training will be beneficial.
Travel Requirements:
Expected travel time is greater than 50% for this position.
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. and its subsidiary and affiliate companies provide 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.
Preferred Job-related Experience:
Adequate experience as a CRA I, performing administrative and on-site monitoring on a variety of studies, or equivalent experience is required.
At least 1 or more years as a CRA I or equivalent position is preferred.
Additional Eligibility Qualifications:
Must be proficient in Microsoft Office, , virtual communication platforms and other technology required. Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff.
