The Sr. Clinical Research Associate is responsible for conducting the day-to-day management of activities associated with the execution of clinical trials. The Sr. CRA ensures that clinical tasks are being performed in compliance with all regulations, Good Clinical Practices, and company policies and procedures. Under direction of the Clinical Trial Manager, the Sr. CRA will be responsible for data management, study materials and logistics.
Summary of Position with General Responsibilities:
Under the supervision of the Clinical Trial Manager, the Sr. CRA will:
• Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget;
• Manage and develop study related documents and materials such as protocols, case report forms, study manuals, informed consents, websites, recruitment materials and other study related tools.
• Oversee development and management of clinical database for the trial.
• Help manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
• Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, payments
• Participate in regular project team meetings;
• May function as the main contact person with investigative sites, vendors and other functional areas
• Supervise department personnel as needed.
• 6+ years experience in Clinical Research
• 2+ years in Industry
• Strong computer skills with a proficiency with MS Windows based applications;
• Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials;
• Excellent communication skills (oral and written);
• Strong organizational skills;
• Ability to work independently and manage multiple tasks and personnel
Additional Desirable Qualifications Skills and Knowledge:
Previous experience with peripheral vascular devices is preferred
Education and/or Experience:
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...