St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 10:31:10.509146USAPlymouthClinical 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/jobUSADallasSenior Clinical Research Associate Job Requisition #: NMD3166 Date Posted: 04/16/2012 Category: Clinical Nursing Location: Dallas - TX - 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 our Neuromodulation Division: Job Overview Plan, 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. Major On-going Responsibilities: • Develops assigned investigational plans (including clinical protocol, case report forms, and all required documents) • Develop and coordinate IDE application submissions • May lead and direct the work of others/trains/mentors junior personnel • Implements clinical monitoring procedures from inception to end of clinical studies • Participates on multidisciplinary product/project teams • Conducts internal and external audits • Plans study budgets • Works with Clinical Operations on study site contracts/budgets • Train clinical site personnel and investigators • Assure study compliance and all safety information is reported appropriately • Maintain communication with sites • Present clinical study updates and summaries in written and oral reports • Assure accurate, complete and current records are maintained • Monitors (initiation, periodic and close-out visits) all clinical studies according to written GCPs and SOPs Experience and Training: • Bachelors degree in Nursing/Biology or Medical Field • 5+ years experience clinical monitoring • Trained in Good Clinical Practices • Implant device clinical monitoring experience desired • Previous experience using word processing, spreadsheet, data management software programs required • The individual must posess technical writing and fundamental problem solving skills • Individual must have project management skills • Individual must have the ability to travel Other Skills and Characteristics: • Candidate should possess good writing and communication skills • A demonstrated comfort using personal computers and the willingness to learn specific software applications are essential. • The individual should have a scientific/medical background, interest in research methology, the ability to work independently. • Relies on extensive experience and judgement to plan and accomplish goals • Performs a variety of tasks • The candidate should be innovative, people-oriented with good interaction skills. • May lead and direct the work of others • May train department personnel • May audit team work activities • A wide degree of creativity and latitude is expected. |E-mail this position Submit Resume or C.V.2012-04-16 18:49:44United StatesSt. Jude MedicalTexasNMD3166TXDallas, TX27925649http://jobs.sjm.com/xml/27925649/jobUSASylmarClinical Research Associate III Job Requisition #: 12769 Date Posted: 03/27/2012 Category: Clinical Location: Sylmar - CA - 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 at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working 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. Requirements/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. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:30United StatesSt. Jude MedicalCalifornia12769CASylmar, CA27532238http://jobs.sjm.com/xml/27532238/jobUSASylmarClinical Research Associate II Job Requisition #: 12800 Date Posted: 03/30/2012 Category: Clinical Location: Sylmar - CA - 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 at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working 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. Requirements/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. Desired 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. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:15United StatesSt. Jude MedicalCalifornia12800CASylmar, CA27532227http://jobs.sjm.com/xml/27532227/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/jobUSANoneSr. Clinical Research Associate - Regional Job Requisition #: 11541 Date Posted: 08/24/2011 Category: Clinical Location: Central - Region - 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 our Cardiovascular Division: Job Overview The 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. Responsibilities: • Follows department Standard Operating Procedures. • Monitors clinical investigations for multiple studies and sites simultaneously, to a. Assure protocol compliance per applicable regulations; b. Assure subject rights, safety and welfare are protected; c. Assure data integrity through completeness, accuracy, legibility and logicalness. • Completes monitoring reports and follows open action items in a timely basis. • Assists Clinical Research Associate in setting 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 in organizing Investigator and Data Safety Monitoring Board meetings. • Conducts monitoring visits to assure protocol compliance and data integrity. • Generates presentations when requested by investigators or AGA personnel. • Generates status reports and sends to investigators on a regular basis. • Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries. • Acquires professional, product and market expertise via independent reading, networking and training. • Travels approximately 85%. • Participates in professional activities outside of normal business hours. • Other duties as assigned. Education, Experience, Personal and Technical Skills: • BA/BS in business, medical science or nursing (or equivalent experience). • 5-8 years experience in Clinical Research, preferably in a medical device company. • 5 years monitoring experience, preferably in a field position. • Strong ability to prioritize and organize multiple projects, simultaneously. • 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.2011-08-24 18:47:22United StatesSt. Jude MedicalNone11541NoneVirtual, USA23220963http://jobs.sjm.com/xml/23220963/job