Senior Clinical Research Associate

Division: Atrial Fibrillation Division (AFD) Location: Minnetonka, MN 55345 Status: Full Time, Employee Job Category: Biotech/R&D/Science Work Experience: 7+ to 10 Years Education Level: Bachelor's Degree Career Level:Experienced (Non-Manager) Company:St. Jude Medical Senior Clinical Research Associate Organizes and supervises new clinical studies. •Acts as primary author for clinical study protocols and supporting documents (informed consent, case report forms, training materials, etc). •Investigator, IRB and IACUC approval contacts for both human and animal studies. •Primary responsibility for recruitment, selection, and training of clinical investigators with respect to protocol and data submission requirements. •Responsible for completing appropriate Study Organizer forms (i.e. Request for CRD number, Request for Initial Study Organizer Information, etc). •Provides technical assistance to centers (assist with initial procedures, etc.). •Represents the clinical department on new product development teams. •Drafts and obtains nondisclosure, investigator agreement, research contract and financial agreements and investigator financial disclosure. •Visits sites for pre-investigational reviews. •Responsible for safety committee (e.g., DMC) member selection, member communication, contracts, etc. •Responsible for management of core labs (core lab selection, contract negotiations, etc.) •Responsible for planning Investigator Meetings.   Supervises ongoing clinical studies. •Performs site initiation visits and close out visits •Performs on-site monitoring/audits of source documents and study compliance at each investigational site as defined by the Clinical Investigation Plan. •Monitors data input/database maintenance activities of database team during ongoing clinical studies. •Responsible for accurate, complete and timely data submissions by clinical investigators and implementation of corrective action, if necessary. •Assists the Clinical Trial Coordinator with investigational site compensation programs. •Supports investigators wishing to publish or present their experience with company products. •Prepares and submits forecasts of investigational devices to Manufacturing to assure adequate supply, and maintains records of device shipment and storage. •Reports and gains approval for any protocol changes or deviations. •Reviews clinical data for completeness and identifies any adverse effects. •Reports unanticipated adverse effects to Regulatory Affairs personnel. •Provides in-house (Sponsor) audits of clinical studies   Serves as principal clinical resource for regulatory submissions. •Authors appropriate clinical sections (e.g., report of prior clinical studies, instructions for use, etc.) for IDE submissions. •Drafts clinical summary sections of PMA applications. •Prepares appropriate interim reports (e.g., annual study update) for FDA and IRBs   Phase V trials •Act as primary author for Phase V clinical study protocols and supporting documents (informed consent, investigator and IRB approval contacts, as required.  •Authors or co-authors appropriate sections of clinical summary sections for manuscripts on these trials.   Other activities •Serves as technical resource for marketing and educational programs. •Participates in professional organizations (e.g., Medical Alley, RAPS, Society of Clinical Research Associates, Association of Clinical Research Professionals) to maintain expertise and develop effective study techniques. •Clinical Affairs representation on project team. •May supervise other Clinical Affairs personnelRequired Qualifications:•B.S. in biological or medical/clinical sciences (e.g., Physiology, Nursing or Physician Assistant) or other degree with 7 years of related experience in drug, medical device or epidemiological MultiCenter IDE or IND studies. •5 or more years related experience in drug, medical device, or epidemiological MultiCenter IDE or IND studies, or equivalent. •Excellent communication and interpersonal skills with demonstrated ability to maintain ongoing communications with department staff, clinical study site personnel, and other SJM employees. •Working knowledge and experience with statistical concepts and principles. •Demonstrated ability and/or experience in physician/patient contact. •Computer literacy. •Has in-depth knowledge of IDE, PMA, 510(k) or equivalent and GCP procedures. •Must be able to travel up to 50% Qualified Candidates may apply online at www.sjm.jobs.  Reference job number AF11817. St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.