This position is responsible for coordination of clinical studies to meet regulatory and client objectives through the life-cycle of the clinical study, including a range of activities from protocol development through data analysis.
Develop and maintain a working knowledge of FDA and other regulatory requirements that impact global clinical studies including ISO 14155, ICH GCP, and JGCP;
Responsible for achieving study objectives by working with team members to set priorities and milestones, while resolving project conflicts;
Understand and accept customer requests with an "I can help you" attitude;
Coordinate, develop and/or review all essential clinical study-related documents;
Establish and maintain close working relationships with clinical site personnel, electronic data capture (EDC) vendors and other clinical vendors, and client stakeholders through exceptional communication on a regular basis;
Responsible for database management and statistical analyses;
Track study metrics (progress) in order to lead investigative site and study team resources toward achievement of milestones;
Lead meetings with investigative sites, physicians, and vendors as needed to ensure the success of the clinical study;
Train the study team, including investigators, site research staff, and vendors on study requirements;
Lead study team meetings with both internal and external stakeholders;
Respond promptly and appropriately to study issues raised by investigative sites, monitors, and vendors;
Work closely with others to ensure that appropriate resources are available for the project's success and that they are appropriately informed in a timely manner to offer guidance in resolving issues;
Participate in the statistical analysis, summarization, and reporting of clinical data for regulatory or marketing purpose throughout the course of the study; and
Travel as needed- (once restrictions are lifted)
Bachelor’s degree with significant relevant experience is required;
Master’s degree in Health, Life Sciences or Biomedical Engineering is preferred;
Previous experience in the conduct of clinical studies is very beneficial;
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, scientists 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;
Sufficiently assertive to deal with confrontational situations and resolve conflicts;
Experience in writing technical documents; and
Willingness and ability to travel as needed.
Current U.S. work authorization and proof of FDA authorized COVID19 vaccination are required for this position.
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.