Overview

This position is responsible for working closely with MED staff and clinical site personnel on the conduct of clinical studies, including assuming responsibility for coordination of clinical studies to meet regulatory, clinical and client objectives.

Responsibilities

• Work with management to evaluate and support new clinical projects;
• Work with Marketing to develop strategies for customer identification and outreach and to communicate with potential customers;
• Assist with the development of a clinical strategy for a project, product/technology or area of treatment that meets customer objectives; participate in meetings related to the strategy and offer leadership during those discussions;
• Establish customer trust through communication and a commitment to exceeding expectations;
• Establish and maintain close working relationships with clinical site personnel, vendors, and other stakeholders through exceptional communication on a regular basis to ensure the success of the clinical study;
• Develop and maintain a working knowledge of FDA and other regulatory requirements that impact global clinical studies including ICH GCP, JGCP and ISO 14155;
• Write clinical protocols, CRFs, monitoring reports and other required documentation in support of clinical trials, as necessary;
• Coordinate aspects of clinical operations including allocation of resources, training, assessment of vendors and/or contractors, resolution of issues, etc.; and
• Participate in short and long-term strategic planning for the clinical team.

Qualifications

• Advanced degree in Life Sciences or Engineering required; MS, PhD, RN, MD, or equivalent;
• Minimum of 5-10 years of experience in the conduct of clinical studies for medical devices (or five years of experience with Cook)
• Proven ability to exercise sound judgment in decision making;
• Conscientious, influential person with an outstanding work ethic and strong personal discipline;
• Ability to interact with physicians, clinical trial personnel and company executives in a professional and personable demeanor in a variety of settings and interactions;
• Willingness and capability to handle multiple projects and responsibilities;
• Excellent organizational, leadership, and problem-solving skills;
• Excellent written, listening, and verbal communication skills;
• Ability and desire to work in a collegiate team atmosphere; including communicating and working constructively with colleagues;
• Willingness and ability to travel 25% of the time.
• Qualified candidates must be legally authorized to be employed in the United States. MED Institute/Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position