Sr Clinical Research Specialist Job
Job Code - 81807
Position - Full Time - Regular
Job First Active on: Wednesday, April 04, 2012
Sr Clinical Research Specialist
The Sr. Clinical Research Associate is responsible for establishing, managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met. This position may also serve as a trial manager depending on the complexity of the trial and may provide work direction to other team members supporting the trial. The role ensures that clinical study management including the design, initiation, management, monitoring and closing of the study are appropriately executed for either their assigned sites or study if acting in the role of study manager.
• Follow all work/quality procedures to ensure quality system compliance and high quality work.
• Provides project and study management and assures successful conduct of assigned clinical studies. This includes interfacing with representatives from key functional groups including Field Clinical Engineering, Database Administration/Data Management, Statistics, Clinical Quality, Reimbursement, Regulatory Affairs, Marketing, International Clinical Groups, and Product Development (as needed).
• Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs; may include development of global clinical strategy.
• Develops the required clinical documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan) in consultation with the cross-functional team, investigators, and the core clinical team.
• Establishes selection criteria for principal investigators and investigative sites and drives center selection process.
• Responsible for site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
• Assures training of investigators, center staff and Medtronic clinical staff.
• 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.
• Prepare accurate and timely monitoring reports to study management and follow action items through resolution.
• May review monitoring reports from team members if acting as study manager.
• Ensure accurate inventory accountability of investigative product at clinical sites
• Facilitates meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees.
• Supports interactions with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings regarding requirements and results of the study.
• Ensures 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.
• Evaluates clinical data/information and prepares interim and final reports.
• May provide input and support for launch, education, and marketing of products.
• May author/co-author results of studies in the medical literature.
• May develop study budget and manage study spending to plan.
• Provides feedback and performance management input for clinical study team members as capable and required.
• May interview and participate in hiring decisions for clinical personnel.
• May represent clinical on the therapy or product development core team, depending on experience and technical expertise.
• 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 OR MS, MA, or MPH with 2+ years experience or PharmD, PhD, DVM, or MD
Physical Job Requirements
REQUIREMENTS - QUALIFICATIONS: Sr Clinical Research Specialist
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