Clinical Research Project Specialist
CryoLife - Kennesaw, GA

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Position Summary
Provide pre-clinical and clinical support for various CryoLife products and services.

Responsibilities
Provide Clinical Research project support in developing protocol, informed consent forms, case report forms, handouts,
SOPs, analyses, etc. as needed. Prepare monthly status reports.
Conduct pre-clinical, clinical and post approval studies.
Serve as liaison between CryoLife and investigational sites to coordinate and document clinical research studies.
Collect, analyze, present, and distribute clinical data.
Assist with identifying required biocompatibility testing, contract development, and report generation.
Generate basic statistical analyses for technical support of product line.
Conduct literature reviews and write research summaries related to product.
Interface with various CryoLife departments for the purpose of technical training.
Assist in the continued development and management of clinical research databases.
Prepare product Instructions for Use and assist with labeling and labeling changes.
Evaluate and report on adverse events, complaints, and failures associated with the product line, and complete
necessary product Clinical Evaluation Summaries and any other reports necessary to support regulatory submissions.

Requirements
1-3 years of experience in clinical research in the medical or biomedical industry.
Bachelor's or Master's degree in biological science, epidemiology, engineering, statistics or another science-related field.
Intermediate statistical analysis skills.
Computer skills, including spreadsheets and relational databases.
Excellent communication and interpersonal skills
Ability to manage multiple projects and prioritize job responsibilities.
Willingness to travel if needed.


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About this company
CryoLife is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries...