Clinical Research Spec Job
Job Code - 81938
Position - Full Time - Regular
Job First Active on: Wednesday, April 11, 2012
Clinical Research Spec
The Clinical Research Associate (CRA) assists the study manager and has the responsibility for managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The role focuses on assigned areas of clinical study management including the design, initiation, management, monitoring and closing of clinical studies.
• Follow all work/quality procedures to ensure quality system compliance and high quality work.
• Responsible for or assists with writing plans, strategy, and guidelines. Performs activities and generates reports for one or more significant subparts of the study (e.g., monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, study training, patient informed consents).
• Develops or assists the study manager with the development of the required clinical documents (e.g., Clinical Management Plan, Clinical Investigational Plan), study budget, project schedule, study training materials, and study reports in consultation with the cross-functional team, investigators, and the core clinical team.
• Responsible for or assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
• Responsible for site monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and Medtronic standards, guidelines and policies.
• Ensure accurate inventory accountability of investigative product at assigned sites.
• Prepare accurate and timely monitoring reports and follow action items through resolution.
• Assists with writing of abstracts, manuscripts, and sections of reports.
• May facilitate or assist with meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees.
• May assist the Quality organization with project and investigator file audits.
• Provides coaching for entry level clinical study team members as capable and required.
• Will ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc) and implement contingency plans as needed
• Responsible for accurate and timely adverse event reporting during the study.
• Will ensure site adherence to FDA, Regulatory, IRB and Medtronic requirements.
• Work with investigators to quickly and effectively resolve problems.
• BS or BA with at least 2 years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable Or MS, MA, or MPH degree
• Advanced degree (e.g., MS, MA, MPH, PhD, PharmD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field).
• BS or BA with 4 years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable.
• MS, MA, or MPH with 3 years experience or PhD, PharmD, DVM, or MD with 2 years experience supporting clinical research
• At least one year monitoring experience preferred
• Ability to coordinate study-planning efforts within the clinical department and with other business groups, including defining customer requirements and managing expectations
• Demonstrated ability to identify study issues and implement solutions, including identifying and involving the appropriate decision makers
• Demonstrated ability to anticipate data needs and implement tools for effective study management
• Ability to motivate and hold individuals accountable to deliverables; ability to achieve objectives and milestones
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
• Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals.
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
• Willingness to accept challenging assignments and engage in relevant developmental activities
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
• Demonstrated ability to clearly and effectively communicate verbally and in writing
• High attention to detail and accuracy
• Proficient knowledge of medical terminology
• Experience with Microsoft Word, Excel, PowerPoint and familiarity with web-based applications
Physical Job Requirements
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Spec
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