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.
- Contributes to the development of and implements protocols and informed consents for research studies.
- Provides guidance on any protocol related issues.
- Manages and oversees budget for one or more research projects.
- 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 writing and reviewing protocols, analysis plans, reports, and manuscripts.
- Provides input with questionnaire development, analysis, study design, and material management.
- Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and FHI 360 Standard Operating Procedures.
- Conducts site visits to assess protocol and regulatory compliance and manages required documentation.
- Updates and maintains project specific tracking tools.
- May function as project manager on assigned projects taking on a lead role of achieving specific milestone goals to completion.
- Responsible for ensuring that data will pass international quality assurance audits.
- Represents FHI360 in the global clinical research community and develops and maintains collaborative relationships with investigational sites and clients.
Applied Knowledge & Skills:
- Reviews and approves the work and written reports of team members.
- Proven clinical monitoring skills.
- Development and preparation of applicable study tools and job aids.
- Demonstrates effective management skills to at least one staff member.
- Demonstrates project management capabilities including: planning, tracking of milestones/deliverables, and monitoring of resources and budget requirements.
Problem Solving & Impact:
- Works on complex problems that require analysis or interpretation of various factors.
- Exercises independent judgment in determining methods and techniques to accomplish results.
- Decisions could have a major impact on the management and operations of an area within a department
Supervision Given / Received:
- Determines and develops plans and procedures on new assignments and directs the work of others.
- Typically reports to a Manager.
- May act as team lead and mentors staff on training, systems, policies, and regulations.
Education: Bachelor's Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
- Requires 4+ years of clinical research monitoring experience.
- CRP or SoCRA certification preferred.
- Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
- Must be able to read, write and speak fluent English.
- Advanced degree or its international equivalent preferred.
- Global clinical research work preferred.
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.