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. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Senior Clinical Research Associate - South East
Description
This is a field based position ideally located in the South East. Must have the ability to travel throughout the US.
General Summary:
Employees at this level are deepening the critical job competencies and are taking on projects of a more complex nature. A well-rounded operational/functional/scientific skill set has been fully mastered and the employee may be beginning to deepen his or her experience in some therapeutic areas. Employees at this level will lead and mentor junior level contributors.
Minimum Education & Experience:
Education: Bachelors Degree in Science or Healthcare Related Field, Masters preferred.
Professional Experience Years: 3-8 years experience in clinical/scientific research, medical experience. Minimum of five years with Bachelors and minimum of 4 years with Masters. Minimum of 4 years monitoring experience required. Neurovascular experience preferred.
Duties and Responsibilities:
· This field based role involves 50-80% travel.
· Track Screening & Enrollment and identify issues & address globally.
· Independently confirm that site regulatory documents match SMF, act as a subject matter expert for Junior staff.
· Contact sites on a consistent basis to assess study compliance and mentor Junior colleagues.
· Address non compliance issues at investigative site and develop CAPA if necessary and mentor Junior staff.
· Notes global trends as a functional lead and reports to project management.
· Manages deliverables.
· Disseminates project information.
· Leads clinical team meetings on LTF studies under Sr. Project Management guidance.
· Tracks metrics data.
· Monitor Case Report forms against medical records on complex trials.
· Write confirmation letter, site visit report and follow up letter. Assist CRA 1 in these tasks.
· Mentors junior staff on the conduct of site close-out visits.
· Conducts site qualifications visits and mentors junior staff on completing these visits.
· Conducts site initiation visits and mentors junior’s junior staff on completing these visits.
· Assist Junior staff in scheduling monitoring visits to ensure project timelines are met and the monitoring plan is followed.
· Present at study-specific teleconferences and investigator meetings.
· Mentor junior staff in conducting device accountability at investigational sites; Assist in resolving issues.
· Train new study coordinators and junior monitors on ICH/GCP guidelines and study specific requirements.
· Trains junior staff in identifying adverse events during monitoring and ensuring that sites complete appropriate reporting.
· Reviews summaries of medical publications and past study summaries.
· Delivers high quality clinical input to core teams.
· Utilize clinical knowledge to improve clinical compliance across department and at external sites with compliance issues.
· Mentors CTC/CRA1/CRA2 and new employees.
· Train all Junior staff on clinical operations and career growth.
· Train on protocol and assist with 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.
· Ensure up to date training.
Personal Skills/Attributes/Qualifications
· 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.
· Establishes a model for excellence and achieving objectives. Enthusiastic about the work he/she is producing as well as the overall direction of the business.
· 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, consistency, calm under fire, and a reputation for high quality work.
· Conveys enthusiasm for work and initiates activities without prompting. Seeks out new challenges and puts in extra effort to accomplish results. Searches for opportunities to increase efficiency and effectiveness within the business.
· Skilled in using BSC’s institutionalized desktop tools and applications to accomplish daily business activities, examples include Microsoft Windows Packages, Oracle, Hyperion, Closed Loop, Ariba, etc.
· Describes the use of a variety of influencing approaches when communicating with and persuading key contacts, stakeholders and helping to define and shape business decisions.
· Behaves as a role model.
· Guides the development of new employees and junior staff.
· Promotes teamwork.
· Inspires others.
