Developing and maintaining an exemplary research team is essential to the success of a quality clinical research program. Functions such as regulatory compliance, protocol maintenance, patient care, tissue acquisition and transmittal, data collection and submission, and general administration are among the many tasks on which quality clinical research, protection of subjects' rights, and advancement of research region.
Responsible for the profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives. Serving as a supervisor and mentor to all direct reports as detailed by the org. chart. Working closely with the Director of Operations, develops and implements business plans for achieving the strategic and tactical goals and objectives of the business. Participates in the weekly Business Development (BD) calls to review the site's pipeline for planning purposes and to provide feedback. Oversees plans for recruiting subjects into each study. Oversees the preparation and submission of regulatory materials to sponsors and oversight organizations.
The Clinical Research Associates (CRA) will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of cardiovascular and peripheral vascular diagnostic and therapeutic medical devices. CRAs support study activities to meet protocol and corporate objectives, maintaining regulatory compliance and professional integrity for our internal and external stakeholders.
The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.
Clinical trial assistants are support staff. Depending on the setting and site needs, basic medical duties such as taking blood or performing lab tests are routine.
Staff Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; executing regulatory product submissions, from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and post-market activities, as required; exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.