CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator)
4 Year Degree
Orthopedic implant manufacuture searching for a candidate to fill the role of Director of Clinical Research.
The Director of Clinical Research is responsible for defining the clinical research strategy and management of all clinical studies. The Director will manage operational and logistical tasks of clinical development to ensure efficient organization and execution of research within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IDE, 510(k) guidelines, etc. The Director will coordinate the efforts of internal and external resources to ensure patient recruitment, trial site selection, plan optimization and execution of data acquisition.
Main duties and responsibilities:
Set strategic direction and leads prospective and retrospective clinical research
Manage clinical research and operations including design and initiation of clinical trials to optimize tactical and clinical value through U.S. site selection and data
Coordinate and oversee clinical trials to support regulatory submissions (PMA, IDE, 510(k)), as well as post-market clinical trials and clinical preference
Clinical study project management including:
Case Report Form (CRF) Development
Site Management and Study Monitoring
IRB Approvals and Management
Site Qualification Visits
Site Initiation Visits
Training the Clinical Sites to the study protocol
Site Close Out Visits
Work with external sites to ensure expedient patient recruitment in conjunction with
Participate in defining clinical application of Medacta products and contribute in the development of post-market clinical
Author and/or work with others to develop publications based on the results of the clinical
Provide updates and status reports to senior management on a regular basis; report on performance against
Manage the budget for clinical research. Ensure overall operation is within the approved budget and
Develop and implement SOPs for clinical research/trials and related
Ensure compliance with all applicable regulatory standards related to clinical research/trials and interactions with physicians.
Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to the product development process, marketing, and field sales
Interface with departments within and outside of the company Accounting, R&D, Regulatory Affairs, Product Development and Marketing.
Manage outside partners/service providers
Represent the company at major annual
Key Skills and Competencies required:
Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met
Demonstrate excellent communication skills (verbal and written).
Ability to develop and give presentations on technical and regulatory
Ability to train/mentor
Ability to effectively deal with a variety of conflicting issues and diplomatically solve those
Ability to read, analyze, and interpret complex technical documents and
Ability to define problems, collect data, establish facts, and draw valid
Strong experience with Microsoft Office (Excel, Word, Powerpoint)