Summary of the position:
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 FHI Clinical’s systems and procedures as appropriate.
Essential functions:
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 Clinical 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 FHI Clinical in the global clinical research community and develops and maintains collaborative relationships with investigational sites and clients.
All other duties as assigned.
Knowledge, skills, and abilities:
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
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.
Position Requirements
Education: Master’s degree or its international equivalent with 7-9 years of experience or Bachelor’s Degree or its International Equivalent in Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development, or related field with 9-11 years of experience . At least five (5) years of previous clinical research experience including assisting with protocol development, clinical monitoring, study implementation, study close out, project management, analysis, and reporting. Supervisory or management experience preferred. Global clinical research work preferred Or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job.
Additional Eligibility Qualifications: CRP or SoCRA certification required. Project or technical leadership experience required. 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. Must be able to read, write and speak fluent English.
Physical Expectations:
Typical office environment
Ability to sit and stand for extended periods of time; ability to life 5-50 lbs.
Travel Requirements:
Expected travel time is 25% 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. 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.
Apply via :
fhi.wd1.myworkdayjobs.com
