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| Senior CRA - Job # 1921 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position. Our Client is a rapidly growing, privately held medical device company based in Raleigh-Durham NC.
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Essential Duties and Responsibilities:
We are currently seeking a Senior CRA to oversee the conduct of medical device clinical research studies and ensure compliance with study protocols, standard operating procedures (SOP), U.S. Food and Drug Administration (FDA) regulations, institutional review board (IRB) requirements, and International Conference on Harmonisation (ICH) Good Clinical Practices (GCP).
Responsibilities include:
- Responsible for preparation and maintenance of study documentation including study protocols, investigator agreements, study contracts, investigator brochures, IRB approvals and progress reports, case report forms, informed consent documents, investigator payments, device accountability records, adverse event reports and study reports.
- Collaborate with all company departments to ensure studies meet business goals and timelines.
- Serve as a Sponsor liaison with clinical investigators, IRBs, and contract research organizations (CRO).
- Assist in the selection, qualification, and training of clinical investigators and investigational site staff. Conduct study initiation, monitoring and close-out visits at investigational sites.
- Monitor, collect and manage data to ensure accuracy and compliance with GCPs.
- Oversee and ensure compliance of Sponsor, clinical investigators and CROs with study protocols, SOPs, GCPs and state and federal regulations. Analyze and interpret clinical data in collaboration with consultant statisticians.
- Prepare presentations, publications and clinical study reports to support regulatory submissions, product registrations, research and development needs and marketing objectives.
- Identify and solve complex issues that affect the compliance and quality of clinical studies.
- Participate in clinical study audits and inspections and resolve audit issues in a timely manner.
- All other tasks that may be assigned from time to time by corporate management.
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Requirements:
- Bachelor Degree minimum.
- Minimum three years experience in monitoring or conducting medical device clinical studies in compliance with ICH and FDA regulations.
- Prior monitoring experience and expertise in clinical studies on medical devices.
- Knowledge and prior experience in ophthalmology.
- Hands-on interaction with physicians and patients in the use of medical devices.
- Comprehensive understanding of applicable FDA regulations, Good Clinical Practices and international standards.
- Excellent organizational, interpersonal, communication and computer skills.
- Willingness to travel (up to 75%).
- Minimum three years experience in monitoring or conducting medical device clinical studies in compliance with ICH and FDA regulations.
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 Our Client offers a competitive salary and exceptional benefit package.
For confidential consideration please submit a resume and salary requirements to
claire@fullscalesolutions.com.
Full Scale Solutions is an equal opportunity employer.
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