Manage assigned departmental project tasks/systems in principal areas of responsibilities identified below.
Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.
Liaison between CryoLife, investigational sites, and CROs (as applicable) to coordinate and document clinical research studies. Respond to written and telephone inquires from investigational sites, as applicable.
Collect, query, analyze, and present clinical data. Develop and maintain any applicable clinical research databases as necessary.
Identify required biocompatibility testing, work with legal to develop a contract and ensure timely completion and accuracy of final report.
Conduct basic statistical analyses for technical support of product line.
Conduct literature reviews and write research summaries related to product line.
Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
Prepare product Instructions for Use and assist with labeling and labeling changes (including receipt of applicable translations).
Generate final clinical study reports.
Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
Evaluate and report on adverse events, complaints, and failures associated with the product line.
Attend surgical congresses as necessary.
Complete necessary product Clinical Evaluation Reports and/or any other reports necessary to support regulatory submissions.
Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) marketing literature.
Responsible for site recruitment/selection, investigator meetings, and management of clinical study sites.
Ensure that clinical trials are conducted in accordance with applicable standards and regulations.
Oversee project budgets, budget change forms, accruals, and monthly reports.
Other assigned responsibilities (including previously identified tasks being performed at a higher level than one’s current title)
Minimum 4-6 years experience, within the medical/biomedical industry.
Experience managing a clinical project team and Phase III clinical studies.
BS or MS degree in biological science, epidemiology, engineering, statistics, or other science-related field.
CRA certification or certification eligible.
Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).