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.
- 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 supervisor.
- Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites.
- Conduct site assessment, initiation, routine, and close-out monitoring visits, may require supervision.
- Complete accurate monitoring visit reports.
- Develops training materials and conducts training for study implementation based on company policies and SOPs.
PROBLEM SOLVING & IMPACT:
- Works on problems of moderate scope that require a review of various factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Decisions generally affect own job or specific functional area.
- Must have a working knowledge of concepts, practices and procedures for conducting clinical research studies.
- 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.
- Exceptional attention to detail
- 5-7 years of experience in some area of clinical research or MS/MA with 3-5 years of experience in some area of clinical research.
- Up to 3 years of previous clinical research experience.
- Strong analytical skills and ability to organize diverse information in a systematic way is essential.
- Excellent interpersonal, oral/written communication, and organizational skills.
- Ability to work in a team consisting of people with different technical backgrounds and with people with varying levels of training.
- Ability to facilitate relationships and interact smoothly and effectively with clients and colleagues.
- Proficiency in Microsoft Office, spreadsheet software and other technology required.
- Strong 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. Exceptional attention to detail.
- Ability to travel up to 50% of the time.
- Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
- Experience with pharmaceutical firms or CROs a plus.
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