Senior Field Clinical Research Specialist.

Medtronic; New York (NY); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company in medical technology is seeking a Senior Field Clinical Research Specialist to oversee clinical research studies and collaborate with cross-functional teams. The role demands expertise in diabetes and clinical research, along with strong project management skills. Candidates should possess a Bachelor's degree with relevant experience in clinical settings. This position allows for remote work and offers significant professional development opportunities.

Qualifications

• 4 years of clinical research or diabetes education experience required.
• 2 years required with an advanced degree.
• Proficient in Microsoft Office, particularly PowerPoint.

Responsibilities

• Oversee clinical research studies and program management projects.
• Train site and sponsor personnel on study devices and protocols.
• Review and interpret data for clinical significance.

Skills

Clinical research

Diabetes training

Cross-functional collaboration

Project management

Data analysis

Education

Bachelor's degree

Advanced degree

Tools

Microsoft Office

Job description

In this exciting role, the Senior Field Clinical Research Specialist (SFCRS) oversees and supports multiple activities in the conduct of clinical research studies and program management projects in compliance with applicable regulatory standards, IRB policies and procedures and Medtronic internal requirements. This position is known internally as the Clinical Research Diabetes Specialist (CRDS) and serves as the device and procedure resource for internal study teams and clinical study sites.The CRDS works with limited supervision in consort with study and department management to perform complex and diverse project duties globally over time zones. The CRDS will establish strong working relationships with cross-functional partners, HCPs, MC2 partners and contractors.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic

This position can be based anywhere in the United States and work remotely. The position will support teams across the US and internationally. Travel can vary greatly depending on study phases with less travel during study planning and maintenance and more travel during study start up. Travel will be about 50% domestic and internally.

A Day in the Life

• Participate in study protocol development, writing, editing and provide clinical and device insights.
• Support each assigned clinical research study by creating site and subject training materials according to the study protocol.
• Partner with R&D, Clinical Education and Technical Communications teams on device training and instructional materials development.
• Train site and sponsor personnel on study devices, systems, and protocol procedures.
• Travel to site locations for training as needed. Serves as liaison between Medtronic personnel and site personnel.
• Lead projects and be responsible for ensuring the attainment of project milestones.
• Field therapy and technical inquiries from sites and study team.
• Develop and implement study surveillance activities including, but not limited to trends in protocol conduct, data integrity and subject engagement, software reports, 24-Hour Technical Support calls, procedure observation and device performance oversight activities.
• Review and interpret data for clinical significance and report summary of findings.
• Communicate study status and performance to internal clinical trial leaders.
• Lead in-depth analysis with study teams that drive efficiency and continuous improvement in processes, systems, products, and overall work performance.
• Gain and maintain knowledge of clinical sites to better understand and assess investigators' capabilities.
• Lead, implement and monitor inter-departmental activities necessary for implementation and completion of assigned clinical research studies with cross-functional groups and global partners.

Must Have : Minimum Requirements

• Bachelor's degree with 4 years of clinical research or diabetes training / education experience
• Advanced degree with 2 years of clinical research or diabetes training / education experience

Nice to Have

• Proficient in Microsoft Office applications; particularly Power Point
• Registered Nurse, Registered Dietitian, Certified Diabetes Care and Education Specialist (CDCES), or CCRA certification (Certified Clinical Research Association) or equivalent
• Experience in Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
• Experience in clinical trials within the medical device industry
• Experience in the management of clinical devices
• Knowledge of applicable regulations including Federal Code of Regulations
• Knowledge / awareness of clinical research design
• Experience in diabetes device training for people with diabetes

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