Principal Clinical Research Associate - Cardio

Biotechnology and Pharmaceutical Principal Clinical Research Associate - Cardio Job Description:Principal Clinical Research Associate – Marlborough, MA – Take your clinical experience to the next level!Delivering on the promise of medical innovation begins at Boston Scientific! By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.General Summary:Employees at this level fully demonstrate the critical competencies required for the job track, are proven experts in one or more therapeutic areas and are relied on to lead highly complex projects. These employees provide therapeutic expertise and mentor project team members.Duties and Responsibilities:? Works with the site selection committee to select appropriate investigative sites with therapeutic experience? Assists project manager in the set up of Trial Master File? Actively establishes relationships with investigative sites? Address non compliance issues at investigative site and develop CAPA if necessary and mentor Junior staff? Develops project plan? Execute in agreement with CPP? Develop and Maintain Relationships? Prepare and Maintain Clinical trial Budget? Leads clinical team? Analyzes metrics data and institutes process improvements to internal and external clinical customers’ reviews for risk management? Reviews background reports for protocols and study plans for all studies in therapeutic area. Summarizes medical publications and past study summaries for complex next generation projects? Delivers high quality clinical input to core teams? Write protocols for less complex studies under guidance of Sr. Project Manager? Utilize clinical knowledge to assess and improve clinical processes within department? Mentors CTC/CRA1/CRA2/Sr. CRA and new employees? Behaves as a role model? Guides the development of new employees and junior staff? Promotes teamwork? Inspires others? Train all therapeutic area staff? Train sites on therapeutic subject matter and protocol interpretation? Site CAPA process and re-training? Lead more complex studies? Participates in start-up activities? Reviews documents? Active as core team member? Executes corrective action plans? Reports complaints? Identifies need for corrective action? Ensures up to date trainingMinimum Education & Experience:Education: Bachelors Degree in Science or Healthcare Related Field, Masters preferred.Professional Experience Years: 7+ years experience in clinical/scientific research, nursing or medical devices/pharmaceutical clinical trials; 3+ years experience in a specific BSC therapeutic area.Competency Expectations:? Develops an understanding of general business principles, industry dynamics, global market trends, environment factors and customer requirements? Considers the vision, direction and goals of the organization when setting business or work priorities. Works to understand and influence the matrixes organization and the dependencies between functions, divisions and regions on decision making.? Recognizes the need for unique or modified approaches to achieving results and adding value to the direction of the business. Plans for change and perceives it as opportunistic.? Develops an understanding of general business principles, industry dynamics, global market trends, environment factors and customer requirements.? Displays insight in analyzing complex situations, considers various approaches and perspectives in addressing problems, and makes timely decisions, anticipating their potential impact and using sound judgment.? The ability to identify, use, control and manage interpersonal skills.? Understands and interprets technical, scientific and clinical information and applies that understanding to product approval activities.? Identifies and assures optimal product and process quality within quality systems and regulatory requirements.? Lead teams to translate issues into actions, make decisions and influence outcomes, collaborate and communicate, and meet project cost, schedule, and performance requirements.? Describes the qualities of financial professionals that enable them to be trusted and believed by management, their team, and other organizations within BSC. These characteristics include honesty, self-confidence, commitment, accuracy, consistencyJob Experience:*Minimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.