Associate Clinical Research Specialist.

Associate Clinical Research Specialist

In this exciting role as an Associate Clinical Research Specialist (CRS), you will have primary responsibility to manage day-to-day operations within the Medtronic physiology lab.

This role reports to the Clinical Lab Manager. The Associate CRS will independently maintain subject recruitment, screening, scheduling, and compensation responsibilities including developing and managing community outreach and laboratory advertising programs.

The Associate CRS will manage clinical study databases and assist with the drafting, distribution and tracking of study paperwork;

case report forms, and informed consents and assist in the laboratory and clinical study operations through maintenance of procedures in one or more of the following areas : production, research and development, quality control / assurance, and / or compliance / environmental safety.

Location : Denver, CO - no relocation assistance

Travel up to 15% (primarily domestic and occasionally international).

Operating Unit

The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth.

The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio.

This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

ACM is a $2B global business focused on airway management and patient monitoring technologies.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins.

Medtronic walks the walk, creating an inclusive culture where you can thrive.

Careers that Change Lives

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR / VR, telemedicine, and much more, agility and responsiveness are key to our success.

Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Implement a study subject recruitment and screening plan, including establishing key community relationships and ensuring subject compensation.
• Work within the local community to identify and develop a diverse and inclusive subject pool.
• Establish and maintain regular communication with research management and product managers
• Develop and maintain appropriate study scheduling tools for subjects and projects.
• Enter data and maintain database of subject demographic information.
• Conduct laboratory support functions such as ordering, stocking, and distributing supplies and equipment, and collecting, washing, and storing equipment.
• Maintain organizational standards : GCP, GLP, CITI training.
• Prepare and maintain general laboratory quality controls and appropriate auditable documentation
• Collaborate in study conduct and study subject communication, interactions, and ensure confidentiality.
• Data coordination- actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements.
• Ensures timely and quality completion of data forms, verifies study data, and generates, manages and resolves data discrepancies.
• May process compensation & identify and resolve compensation discrepancies.
• Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents.
• Assists with periodic audits of clinical study files for completeness and accuracy.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and / or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site and vendor selection.

Must Have : Minimum Requirements

• Bachelors degree required
• 0 years of experience required

Nice to Have

• Bachelor’s degree + 2 years of clinical coordination experience in the medical device industry
• Experience in pre-market / investigational and post market studies
• Experience with database management, subject recruitment and consenting, data collection, and clinical reporting
• Knowledge and familiarity with the operations of a medical research laboratory
• Ability to follow established guidelines / procedures for the preparation of various administrative forms, as well as learn new tasks independently
• Able to read and interpret technical procedures and regulatory requirements
• Experience in medical device clinical product trials and governing regulations
• Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial
• Leadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management
• Demonstrated ability to work effectively on cross-functional teams
• Experience in a high-demand and fast-paced environment
• Strong problem-solving skills
• Community outreach capabilities
4 days ago