Coordinator III, Clin Research - 200177 - Fremont, CA - 0100

Biotechnology and Pharmaceutical Coordinator III, Clin Research - 200177 - Fremont, CA - 0100 Job Description:Senior Clinical Research Coordinator – Fremont, CABy 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!Boston Scientific has an exciting opportunity for a Senior Clinical Trial Coordinator to join a dynamic organization and impact lives around the world!General Summary:Support position in Clinical Research executing all administrative aspects of study management from start-up through closeout. Responsible for assisting and providing support to the members of the clinical project team (i.e. Clinical Research Associates and Project Managers), in order to facilitate the management of pre-approval and post-approval clinical trial processes. Duties and Responsibilities:Under minimal direction of clinical project management, performs clinical trial activities for ongoing clinical trials (local or global) including, status report generation, payment processing and maintenance of: regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files. Assists with archiving study documents for completed clinical trials. Assists with distribution, collection and tracking of regulatory documents (e.g., confidentiality disclosures, IRB approvals, and financial disclosures) to/from study sites. Uses CTMS database (or equivalent) to maintain site addresses, coordinate site payments, track device inventory, track clinical documents, and patient follow-up schedule and visit status. Coordinates subject enrollment-tracking system and prepare reports for project team. Assists with preparation of reports (PMA, annual reports, etc.), and technical or scientific publications, as required. When necessary, assists with the organization of Investigator Meetings. Provides administrative support for Investigator Meetings and Annual Society meetings, including compilation of binder materials, overseeing presentations and scheduling activities. Assists with preparation of Clinical Events Committee (CEC) packets for CEC adjudication meetings. Provides training and mentoring for less experienced trial coordinators. May recommend process improvements to increase team efficiencies and effectiveness. Demonstrates working knowledge of clinical research conduct, laws, regulations, and standards, and complies with applicable BSC SOP's and policies. Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.Minimum Education & Experience:Candidates with strong administrative background, Bachelor-level degree (or equivalent) preferred or minimum 3+ years clinical research experience. Experience in a related field (e.g. medical or research) and/or familiarity with medical terminology preferred.Working Conditions:General office environment and will entail limited travel to other BSC facilities, investigator meetings, and/or conferences.Competency Expectations: Strong verbal and written communication skills. Detail oriented and good problem solving ability. Ability to work on teams and with multiple projects. Excellent computer skills with in-depth knowledge and skilled use of MS Office, Word, Excel, and PowerPoint; demonstrated ability to learn new software packages. Must demonstrate initiative and be capable of working independently on multiple projects.Job Experience:Senior Clinical Research Coordinator – Fremont, CABy 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!Boston Scientific has an exciting opportunity for a Senior Clinical Trial Coordinator to join a dynamic organization and impact lives around the world!General Summary:Support position in Clinical Research executing all administrative aspects of study management from start-up through closeout. Responsible for assisting and providing support to the members of the clinical project team (i.e. Clinical Research Associates and Project Managers), in order to facilitate the management of pre-approval and post-approval clinical trial processes. Duties and Responsibilities:Under minimal direction of clinical project management, performs clinical trial activities for ongoing clinical trials (local or global) including, status report generation, payment processing and maintenance of: regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files. Assists with archiving study documents for completed clinical trials. Assists with distribution, collection and tracking of regulatory documents (e.g., confidentiality disclosures, IRB approvals, and financial disclosures) to/from study sites. Uses CTMS database (or equivalent) to maintain site addresses, coordinate site payments, track device inventory, track clinical documents, and patient follow-up schedule and visit status. Coordinates subject enrollment-tracking system and prepare reports for project team. Assists with preparation of reports (PMA, annual reports, etc.), and technical or scientific publications, as required. When necessary, assists with the organization of Investigator Meetings. Provides administrative support for Investigator Meetings and Annual Society meetings, including compilation of binder materials, overseeing presentations and scheduling activities. Assists with preparation of Clinical Events Committee (CEC) packets for CEC adjudication meetings. Provides training and mentoring for less experiMinimum Education Required: BachelorExpected Travel Time: None Please visit us online at www.bostonscientific.com for more information.