[{"country_short": "USA", "city": "Plymouth", "description": "Clinical Research Associate\nJob Requisition #: 12963\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Research Associate will manage and execute assigned clinical studies with guidance. This will include Support professionalism and scientific expertise of department.\n\nResponsibilities:\nManages assigned clinical study centers\nSets up sites: clinical research agreements, site budgets, IRB Approvals, etc\nPrepares and maintains case report forms, informed consent and other specialized documents for clinical investigations\nConduct study training or other formal training at site and at the study team level\nAssists Regulatory in annual report and progress reports to the FDA\nReviews data forms and DCF generation\nResponsible for data review and approval of DCFs\nGenerates presentations when requested by investigators\nAcquires professional, product and market expertise via independent reading, networking and training\nTravels approximately 30% but varies according to trial needs\nParticipates in professional activities outside of normal business hours\nPerforms other related duties as requested\n\nRequirements:\nBA/BS in business, science or nursing\n3-5 years experience in clinical research including monitoring\nAbility to constructively interact with a range of personalities and range of positions, both inside and outside the organization\nExcellent written and verbal communication skills\nAbility to work independently and take direction from others\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:10:04", "url": "http://jobs.sjm.com/xml/28034728/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate", "reqid": "12963", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034728}, {"country_short": "USA", "city": "Plymouth", "description": "Associate - Clinical Research\nJob Requisition #: 12962\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe 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.\n\nResponsibilities:\n\u2022 Assist with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.\n\u2022 Initiate site activation documentation\n\u2022 Participate in site qualification and site initiation process, including scheduling of monitor activities with site personnel.\n\u2022 Assist in planning and preparing materials for investigator and coordinator meetings.\n\u2022 Assist in training of investigators and coordinators.\n\u2022 Track and report progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.\n\u2022 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\n\u2022 Assist in query generation and resolution.\n\u2022 Assist with core lab data management.\n\u2022 Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues.\n\u2022 Write and/or provides input to the monitoring plan\n\u2022 Provide updates on progress of assigned clinical sites to study management.\n\u2022 Develop expertise with SOP's, GCP's, and regulatory compliance guidelines.\n\u2022 Participate in training/orientation or new employees.\n\u2022 Contribute to ongoing SOP review and development.\n\u2022 Review site changes to informed consent forms.\n\u2022 May create and conduct presentations.\n\nQualifications:\n\u2022 Four year degree in physical science\n\u2022 1-2 years experience monitoring\n\u2022 Experience directly supporting clinical research or similar experience in a medical/scientific area\n\u2022 Knowledge of clinical and outcomes research study design\n\u2022 Working knowledge of GCPs, and regulatory compliance guidelines for clinical trials\n\u2022 Knowledge of medical terminology\n\u2022 Able to travel 40% on average\n\u2022 High attention to detail and accuracy\n\u2022 Strong written and oral communications skills\n\u2022 Able to manage multiple tasks\n\u2022 Good problem-solving skills\n\u2022 Proficient computer skills (MS Office)\n\u2022 Current driver's license\n\nPreferred Qualifications:\n\u2022 Two years applicable health care experience\n\u2022 Advanced degree\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:09:59", "url": "http://jobs.sjm.com/xml/28034726/job", "country": "United States", "company": "St. Jude Medical", "title": "Associate - Clinical Research", "reqid": "12962", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034726}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Research Associate II\nJob Requisition #: 12425\nDate Posted: 02/07/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.\n\nResponsibilities:\n\u2022 Follows department Standard Operating Procedures\n\u2022 Sets up sites: clinical research agreements, IRB Approvals, etc\n\u2022 Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations\n\u2022 Assists Regulatory in annual report and progress reports to the FDA\n\u2022 Organizes Investigator and Data Safety Monitoring Board meetings\n\u2022 Reviews data forms and DCF generation\n\u2022 Conducts field audits to assure protocol compliance and data integrity\n\u2022 Generates presentations when requested by investigators of AGA personnel\n\u2022 Generates follow-up reminder reports and sends to investigators or AGA personnel\n\u2022 Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries\n\u2022 Acquires professional, product and market expertise via independent reading, networking and training\n\u2022 Counsels and trains newly hired CRAs and monitors\n\u2022 Travels approximately 20%\n\u2022 Participates in professional activities outside of normal business hours\n\u2022 Performs other related duties as requested\n\nRequirements:\n\u2022 BA/BS in business, science or nursing\n\u2022 2 - 4 years experience in clinical research including monitoring\n\u2022 Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization\n\u2022 Excellent written and verbal communication skills\n\u2022 Ability to work independently and take direction from others\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-08 07:39:11", "url": "http://jobs.sjm.com/xml/26394667/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate II", "reqid": "12425", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 26394667}]