Medtronic is an Equal Opportunity/Affirmative Action Employer
Partner with lead screening committee facilitator to provide oversight for the Medtronic CoreValve Screening Committee(s). This would include work on domestic and possibly international clinical studies. The Clinical Research Specialist manages cases that go through the screening process. This role will prepare, organize and facilitate the Screening Committee meetings, working closely with the physicians on the committee, the sites submitting clinical data to the committee, and internal Medtronic staff including, study team members, clinical analysts and Therapy Development Specialists (TDSs). The role will be based in Minneapolis (Mounds View) but includes leading meetings in the evenings. A work schedule will be tailored to accommodate this need. This role may also include other Clinical Research Specialist roles and responsibilities, as needed.
SCREENING COMMITTEE PROGRAM
• Gain deep understanding of screening process inner workings and manage program.
• Maintain screening committee meeting schedule and organize each meeting.
• Provide patient list (agenda) for each meeting.
• Distribute screening outcomes per charter defined timelines.
• Act as screening process expert and the primary point of contact for external collaborators.
• Communicate and collaborate effectively with greater team including committee physicians, CRSs, sites, Clinical Analysts, TDSs, as well as other cross functional groups and understand each role.
• Keep accurate metrics on the screening process and routinely update the trial management team and senior leadership.
• Manage risk assessments of patients based on screening data.
• Assure that all necessary documentation has been submitted by the sites or any by other relevant party prior to submission to screening committee.
• Assist TDSs with transition from screening to scheduling of patients.
• Maintain central repository for the archival of screening information.
• Manage upgrades to screening tools such as image-sharing software and web-based collaboration software.
CLINICAL RESEARCH SPECIALIST ROLES & RESPONSIBILITIES
• Interfacing with representatives from key functional groups including Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical groups.
• Determines study objectives, strategy, scope and schedule in order to meet business needs.
• Develops the Investigational Plan in consultation with the cross-functional project team, investigators and the clinical team.
• Selects, interfaces with, and assures training of investigators, center staff and Medtronic clinical staff.
• Interfaces with regulatory agencies regarding requirements and results of the study.
• Ensures adequate monitoring is conducted on all clinical trials.
• Enlists support and specifies tasks for various clinical team members to assure meeting study objectives on schedule.
• Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and advise on direction.
• Bachelor's degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
YEARS OF EXPERIENCE:
• 2+ years of experience with GCPs and regulatory compliance guidelines for clinical trials.
• Prior experience facilitating a committee (Clinical Events Committee, Data Safety Monitoring Board, Adverse Events Advisory Committee, etc.)
• Prior experience working directly with physicians
• 2+ years of direct clinical management experience. A Master’s degree will substitute for one year of experience
• Experience with medical imaging including echocardiography, computed tomography, and fluoroscopic arteriograms.
• Excellent written and oral communication skills and some knowledge of medical terminology.
• High attention to detail and accuracy and ability to manage multiple tasks.
• Excellent prioritization and organizational skills.
• Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations.
• Basic knowledge of clinical research study design.
• Excellent problem solving skills
• Flexible and dependable.
• Works effectively on cross-functional teams.
• Ability to travel as needed
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.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.