New Hope,Minnesota,United States
Trailblazing Innovation for Patients
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients. Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
The Clinical Research Associate II (CRA II) is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of high quality clinical trials for Lutonix products. The CRA II ensures that clinical tasks are being performed in compliance with applicable regulatory standards, Good Clinical Practices, and company policies and procedures.
Summary of Position with General Responsibilities:
- Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget
- Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
- Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
- Participate in site qualification and site initiation process, including review of required site documentation
- Conduct training of investigators and coordinators
- Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
- Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
- Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
- Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues
- Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
- Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
- Participate in regular project team meetings
- Develop and maintain current working knowledge of the disease state & product
- May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts
Education and/or Experience:
- BA/BS or equivalent medical / industry experience
- Minimum of 2+ years experience directly supporting Clinical Research
- Strong computer skills with a proficiency with MS Windows based applications
- Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials
- Excellent communication skills (oral and written)
- Strong organizational skills and able to manage multiple tasks
- Ability to work independently
- Previous experience with peripheral vascular devices preferred
- Previous experience with EDC systems preferred
- Ability to work effectively on cross-functional teams preferred
- Demonstrated ability to work effectively on cross-functional teams
- Valid driver’s license required
- Able to travel 20% on average and up to 50% during peak periods
BA/BS or equivalent medical / industry experience
Minimum of 2+ years experience directly supporting Clinical Research
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.