Senior Clinical Research Associate (253729-560)

Responsible for conducting clinical studies to support Regulatory Affairs submissions and the Marketing and Reimbursement of Smith & Nephew Endoscopy products. Responsible for the preparation of clinical study documents such as protocols, case report forms, site monitoring reports, and study summaries. Manage surgeon contracts to ensure that clinical projects are completed and the required reports prepared. Assists with market preference evaluations prior to product launch. Provide literature reviews of currently marketed devices. Responsible for some compliance activities within the company including design controls, internal auditing, and assuring compliance with GCP guidelines.

1. Responsible for the day-to-day oversight of clinical studies. Responsible for the preparation of study protocols, informed consent forms, case report forms, and other study related documentation. Coordinates and monitors studies to assure compliance with study protocols, regulatory requirements, and GCP guidelines. Creates and maintains of effective tracking tools for study budgets, device inventories, monitoring visits, etc. Responsible for the evaluation of investigators and study sites. Assists with IRB/Ethics committee submissions and secures investigator agreements. Facilitates budget negotiations and contracts. Tracks the flow of study data and prepares periodic tracking reports. Assists with data management, as needed.
2. Member of development team. Assumes the role of clinical lead in the pre-release evaluation process for new or modified products prior to commercialization.
3. Assists surgeons in conducting physician initiated studies. Facilitates budget negotiations and grant contracts. May assist with IRB submissions, protocol and CRF development.
4. Performs literature reviews and provides summaries for risk management activities, marketing purposes, and in support of reimbursement activities.
5. Assists in the preparation of regulatory documents and submissions as needed.
6. Consults with surgeons to gain knowledge of user needs. Reads, understands, and summarizes the medical literature.
7. Participates in assignments outside the scope of clinical research as needed.
8. Assists in improving and maintaining department SOPs and policies current.

Required Skills:Bachelor’s Degree.
5 – 7 years experience in medical device industry, clinical setting, or research field.
Working knowledge of national and international regulations for conducting human clinical trials.
Mastery of federal regulatory requirements and guidelines, including, Good Clinical Practices (GCPs), Quality Systems Regulation (QSR), Declaration of Helsinki, FDA Guidelines, EN ISO 14155, 21 CFR Part 812, and HIPAA requirements.
Excellent understanding of domestic and international product approval process.
Proven organizational and problem-solving abilities
Solid experience working with Microsoft Office (Word, Excel, Outlook, Access, Powerpoint).
Familiarity with statistical concepts.

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