St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 10:34:10.086515USAPlymouthClinical Research Associate Job Requisition #: 12963 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate will manage and execute assigned clinical studies with guidance. This will include Support professionalism and scientific expertise of department. Responsibilities: Manages assigned clinical study centers Sets up sites: clinical research agreements, site budgets, IRB Approvals, etc Prepares and maintains case report forms, informed consent and other specialized documents for clinical investigations Conduct study training or other formal training at site and at the study team level Assists Regulatory in annual report and progress reports to the FDA Reviews data forms and DCF generation Responsible for data review and approval of DCFs Generates presentations when requested by investigators Acquires professional, product and market expertise via independent reading, networking and training Travels approximately 30% but varies according to trial needs Participates in professional activities outside of normal business hours Performs other related duties as requested Requirements: BA/BS in business, science or nursing 3-5 years experience in clinical research including monitoring Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization Excellent written and verbal communication skills Ability to work independently and take direction from others |E-mail this position Submit Resume or C.V.2012-04-20 18:10:04United StatesSt. Jude MedicalMinnesota12963MNPlymouth, MN28034728http://jobs.sjm.com/xml/28034728/jobUSAPlymouthAssociate - Clinical Research Job Requisition #: 12962 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate II position will assist in the planning, designing, and execution of clinical studies under the supervision of the Clinical Manager with focus on compliance to applicable regulatory standards and monitoring of investigational centers. Responsibilities: • Assist with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools. • Initiate site activation documentation • Participate in site qualification and site initiation process, including scheduling of monitor activities with site personnel. • Assist in planning and preparing materials for investigator and coordinator meetings. • Assist in training of investigators and coordinators. • Track and report progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events. • Coordinate and conduct monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports • Assist in query generation and resolution. • Assist with core lab data management. • Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues. • Write and/or provides input to the monitoring plan • Provide updates on progress of assigned clinical sites to study management. • Develop expertise with SOP's, GCP's, and regulatory compliance guidelines. • Participate in training/orientation or new employees. • Contribute to ongoing SOP review and development. • Review site changes to informed consent forms. • May create and conduct presentations. Qualifications: • Four year degree in physical science • 1-2 years experience monitoring • Experience directly supporting clinical research or similar experience in a medical/scientific area • Knowledge of clinical and outcomes research study design • Working knowledge of GCPs, and regulatory compliance guidelines for clinical trials • Knowledge of medical terminology • Able to travel 40% on average • High attention to detail and accuracy • Strong written and oral communications skills • Able to manage multiple tasks • Good problem-solving skills • Proficient computer skills (MS Office) • Current driver's license Preferred Qualifications: • Two years applicable health care experience • Advanced degree |E-mail this position Submit Resume or C.V.2012-04-20 18:09:59United StatesSt. Jude MedicalMinnesota12962MNPlymouth, MN28034726http://jobs.sjm.com/xml/28034726/jobUSAPlymouthClinical Research Associate II Job Requisition #: 12425 Date Posted: 02/07/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department. Responsibilities: • Follows department Standard Operating Procedures • Sets up sites: clinical research agreements, IRB Approvals, etc • Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations • Assists Regulatory in annual report and progress reports to the FDA • Organizes Investigator and Data Safety Monitoring Board meetings • Reviews data forms and DCF generation • Conducts field audits to assure protocol compliance and data integrity • Generates presentations when requested by investigators of AGA personnel • Generates follow-up reminder reports and sends to investigators or AGA personnel • Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries • Acquires professional, product and market expertise via independent reading, networking and training • Counsels and trains newly hired CRAs and monitors • Travels approximately 20% • Participates in professional activities outside of normal business hours • Performs other related duties as requested Requirements: • BA/BS in business, science or nursing • 2 - 4 years experience in clinical research including monitoring • Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization • Excellent written and verbal communication skills • Ability to work independently and take direction from others |E-mail this position Submit Resume or C.V.2012-02-08 07:39:11United StatesSt. Jude MedicalMinnesota12425MNPlymouth, MN26394667http://jobs.sjm.com/xml/26394667/job