Principal Clinical Research Specialist

Position Description

The Principle Clinical Research Associate is responsible for developing strategies and driving processes to meet the milestones of complex clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs.  This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and global nature.  This role works independently and under only general direction.  Major deliverables are reviewed to ensure clinical and business requirements are met.  The position provides work direction and strategic oversight of personnel supporting their trial and may manage a limited number of personnel, when ready, based on their individual career interests and Individual Development Plan.

Position Responsibilities

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 leading the clinical team and being the clinical representative on the core team for therapy or product development.  Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs; may include development of global clinical and reimbursement strategies.  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.  Responsible for reviewing and approving monitoring reports from study team members.  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 and may interact as the clinical representative with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings, regarding requirements and results of the study.  Enlists support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team.  Critically evaluates clinical data/information and prepares interim and final reports.  Performs risk analysis and develops contingency plans for successful study implementation.  Instrumental in development of launch materials based on the clinical claims matrix.  Authors/co-authors results of studies in the medical literature.  Develops study budget and manages study spending to plan.  Develops a cohesive, high-functioning team by providing feedback, mentoring, and performance management input for clinical study team members.  May interview and participate in hiring decisions for clinical personnel.  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.  Facilitates patient screening and enrollment at assigned clinical study sites to ensure adherence to FDA, Regulatory, IRB and Medtronic requirements.  Work with investigators to quickly and effectively resolve problems.

Basic Qualifications

BS or BA with at least 8 years experience supporting clinical research. Clinical research includes industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research, any other clinical research that would lead toward regulatory submission, review and approval for market clearance.  MS, MA, or MPH with at least 6 years experience or PharmD, PhD, DVM, or MD with at least 4 years experience supporting clinical research.  Minimum of 3 years in study management.

Desired/Preferred Qualifications

Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field). MS, MA, or MPH with 6+ years experience or PharmD, PhD, DVM, or MD with 4+ years experience supporting clinical research.  At least one year monitoring experience preferred.   Proficient knowledge of medical terminology.  Significant knowledge of 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.  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.  Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness.  Demonstrated ability to identify clinical evidence and strategies that are in alignment with defined business priorities and product planning strategies that optimally position products for approval and/or provide critical clinical evidence for existing products on the market.  Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers.  Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances.  Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers.  Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills.  Willingness to accept challenging assignments and engage in relevant developmental activities.

Physical Job Requirements

Able to travel up to 35% and at the direction of the Manager.