[{"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": "Dallas", "description": "Senior Clinical Research Associate\nJob Requisition #: NMD3166\nDate Posted: 04/16/2012\nCategory: Clinical Nursing\nLocation: Dallas - TX - 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 our Neuromodulation Division:\n\nJob Overview\nPlan, organize and coordinate clinical studies. Identifies, selects, initiates and closes-out appropriate study sites for clincial studies. Creates all study related documents including clinical study protocols, clincial final reports, informed consents, Case Report Forms, and other documents. Performs investigator training, site audits, and reports progress of the clinical studies. Assure study compliance to study protocol, Domestic and International Good Clinical Practices Guidelines and ANS Standard Operating Procedures.\n\nMajor On-going Responsibilities:\n\u2022 Develops assigned investigational plans (including clinical protocol, case report forms, and all required documents)\n\u2022 Develop and coordinate IDE application submissions\n\u2022 May lead and direct the work of others/trains/mentors junior personnel\n\u2022 Implements clinical monitoring procedures from inception to end of clinical studies\n\u2022 Participates on multidisciplinary product/project teams\n\u2022 Conducts internal and external audits\n\u2022 Plans study budgets\n\u2022 Works with Clinical Operations on study site contracts/budgets\n\u2022 Train clinical site personnel and investigators\n\u2022 Assure study compliance and all safety information is reported appropriately\n\u2022 Maintain communication with sites\n\u2022 Present clinical study updates and summaries in written and oral reports\n\u2022 Assure accurate, complete and current records are maintained\n\u2022 Monitors (initiation, periodic and close-out visits) all clinical studies according to written GCPs and SOPs\n\nExperience and Training:\n\u2022 Bachelors degree in Nursing/Biology or Medical Field\n\u2022 5+ years experience clinical monitoring\n\u2022 Trained in Good Clinical Practices\n\u2022 Implant device clinical monitoring experience desired\n\u2022 Previous experience using word processing, spreadsheet, data management software programs required\n\u2022 The individual must posess technical writing and fundamental problem solving skills\n\u2022 Individual must have project management skills\n\u2022 Individual must have the ability to travel\n\nOther Skills and Characteristics:\n\u2022 Candidate should possess good writing and communication skills\n\u2022 A demonstrated comfort using personal computers and the willingness to learn specific software applications are essential.\n\u2022 The individual should have a scientific/medical background, interest in research methology, the ability to work independently.\n\u2022 Relies on extensive experience and judgement to plan and accomplish goals\n\u2022 Performs a variety of tasks\n\u2022 The candidate should be innovative, people-oriented with good interaction skills.\n\u2022 May lead and direct the work of others\n\u2022 May train department personnel\n\u2022 May audit team work activities\n\u2022 A wide degree of creativity and latitude is expected.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-16 18:49:44", "url": "http://jobs.sjm.com/xml/27925649/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Clinical Research Associate", "reqid": "NMD3166", "state": "Texas", "state_short": "TX", "location": "Dallas, TX", "uid": 27925649}, {"country_short": "USA", "city": "Sylmar", "description": "Clinical Research Associate III\nJob Requisition #: 12769\nDate Posted: 03/27/2012\nCategory: Clinical\nLocation: Sylmar - CA - 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 at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles:\n\nJob Overview\nWorking with limited direction, is responsible for assisting in the coordination of clinical data collection, researching and analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, and ensuring that site administration paper work is both complete and current. In addition, this position ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Coordinates the initiation of the clinical site, conducting clinical site audits, identifying and obtaining missing data and data corrections, maintaining accurate, detailed and complete records of audits and assisting in the reporting of study results. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year course of study. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager.\n\nRequirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of six plus years of experience as a Clinical Research Associate or equivalent experience which could include (but not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc.).Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Comprehensive personal computer skills including experience with word processing software and relevant clinical applications. The ability to concentrate on detail and work independently. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A familiarity with cardiac rhythm management technology, such as pacemakers, Heart Rhythm Society Heart Rhythm Society Certification in Electrophysiology (EP) and Implantable Cardioverter-Defibrillator (ICD)/Pacing or an equivalent certification of expertise, and with the clinical trial process is preferred.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-31 03:43:30", "url": "http://jobs.sjm.com/xml/27532238/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate III", "reqid": "12769", "state": "California", "state_short": "CA", "location": "Sylmar, CA", "uid": 27532238}, {"country_short": "USA", "city": "Sylmar", "description": "Clinical Research Associate II\nJob Requisition #: 12800\nDate Posted: 03/30/2012\nCategory: Clinical\nLocation: Sylmar - CA - 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 at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles:\n\nJob Overview\nWorking under general supervision, applies clinical judgment to identify/resolve data discrepancies and implements corrections as needed. Is also accountable for analyzing and adjudicating adverse events from research sites, coordinating clinical data collection, analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, assists in the proper reporting of study results. In addition, ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations.\n\nRequirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of two plus years of related work experience as a Clinical Research Associate or equivalent (e.g., Research Coordinator) experience which should include (but is not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc. Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks.\n\nDesired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A general familiarity with cardiac rhythm management technology, such as pacemakers, and with the clinical trial process is preferred.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-31 03:43:15", "url": "http://jobs.sjm.com/xml/27532227/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate II", "reqid": "12800", "state": "California", "state_short": "CA", "location": "Sylmar, CA", "uid": 27532227}, {"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}, {"country_short": "USA", "city": null, "description": "Sr. Clinical Research Associate - Regional\nJob Requisition #: 11541\nDate Posted: 08/24/2011\nCategory: Clinical\nLocation: Central - Region - 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 our Cardiovascular Division:\n\nJob Overview\nThe Sr CRA Regional will conduct site initiation visits, monitor clinical data for multiple studies, and conduct close-out visits. Supports professionalism and scientific expertise of the department.\n\nResponsibilities:\n\u2022 Follows department Standard Operating Procedures.\n\u2022 Monitors clinical investigations for multiple studies and sites simultaneously, to\na. Assure protocol compliance per applicable regulations;\nb. Assure subject rights, safety and welfare are protected;\nc. Assure data integrity through completeness, accuracy, legibility and logicalness.\n\u2022 Completes monitoring reports and follows open action items in a timely basis.\n\u2022 Assists Clinical Research Associate in setting 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 in organizing Investigator and Data Safety Monitoring Board meetings.\n\u2022 Conducts monitoring visits to assure protocol compliance and data integrity.\n\u2022 Generates presentations when requested by investigators or AGA personnel.\n\u2022 Generates status reports and sends to investigators on a regular basis.\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 Travels approximately 85%.\n\u2022 Participates in professional activities outside of normal business hours.\n\u2022 Other duties as assigned.\n\nEducation, Experience, Personal and Technical Skills:\n\u2022 BA/BS in business, medical science or nursing (or equivalent experience).\n\u2022 5-8 years experience in Clinical Research, preferably in a medical device company.\n\u2022 5 years monitoring experience, preferably in a field position.\n\u2022 Strong ability to prioritize and organize multiple projects, simultaneously.\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": "2011-08-24 18:47:22", "url": "http://jobs.sjm.com/xml/23220963/job", "country": "United States", "company": "St. Jude Medical", "title": "Sr. Clinical Research Associate - Regional", "reqid": "11541", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 23220963}]