Clinical Monitor

Overview

This individual is responsible for ensuring clinical studies are being conducted in accordance with the study plan/protocol, applicable regulations and signed investigator agreements at each investigative site in order to meet clinical study objectives on behalf of clients.

Responsibilities

• Identify and report to the Project Leader any issues which may need attention at a particular investigative site; support resolution as needed;
• Travel to investigative sites to perform site initiation, periodic and closeout visits, including assessment of study resources, review of on-site data and source documentation, assessment of adherence with the study plan/protocol and applicable regulations, and general support of the physician and his/her research staff;
• Generate detailed and timely site visit reports following each site visit;
• Support the development of study plans/protocols, data collection forms, patient summaries and other study-related documentation as needed;
• Work closely with both the Project Leader and the client to determine priorities and ensure that project objectives are met; and
• Establish trusted relationships with physicians, their research staff, the project team and study sponsors through communication and a commitment to exceeding expectations.

Qualifications

• RN with BSN or MS in Health or Life Sciences required;
• Prior experience in monitoring or auditing, preferably in a clinical application;
• Working knowledge of FDA and other regulatory requirements that may impact clinical studies;
• Conscientious, influential person with an outstanding work ethic and strong personal discipline;
• Willingness and capability to handle multiple projects and responsibilities;
• Sufficiently assertive to deal with confrontational situations;
• Excellent organizational, leadership and problem-solving skills;
• Excellent written and verbal communication skills;
• Ability and desire to work in a collegiate team atmosphere; including communicating and working constructively with colleagues; and
• Willing and able to travel, 50-75% 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