Clinical Research Manager

Overview

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full‑time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0‑2), ensuring compliance with protocols and regulatory standards and directly managing a team of clinicians.

You can learn more about the lab here: EMT Louisville CO Lab Page

Pay Range: $100k–$145k DOE

• Leads a team of clinicians and technicians in carrying out complex study protocols (management may include multiple concurrent studies, multiple participant visits, and travel to other states).
• Responsible for understanding protocol requirements and utilizing critical‑thinking skills.
• Tracks study progress in terms of data‑collection requirements and assists the recruitment team by communicating screening goals.
• Creates case report forms based on the written protocol.
• Develops, completes, and maintains source documents.
• Documents all aspects of trial progress, including adverse events, protocol deviations, device deficiencies, enrollment and screening logs, device accountability, and the documentation required for the Trial Master File.
• Maintains and completes case report forms in agreement with source documentation and in accordance with study protocols.
• Assures clinical supply accountability for assigned trials.
• Secures all sponsor‑supplied devices and equipment.
• Communicates regularly with sponsors and executive management regarding study‑design recommendations, study progress and status, mitigation strategies, and all aspects of the study from start to finish.
• Supervises employees who perform data analysis and clinical execution, carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
• Interviews, hires, and trains employees; plans, assigns, and directs work; appraises performance; rewards and disciplines employees; and addresses complaints and resolves problems.

• Must be a Registered Nurse with a current license in Colorado (BSN preferred).
• Ability to independently perform and train all procedures (e.g., vital signs, laboratory tests) required by the protocol and allowed by licensure or training level.
• Must have no disciplinary action on license history.
• Clinical research experience preferred.
• Ability to lead a team with clear direction, responsible delegation, goal‑setting, and performance management; prior management experience preferred.
• Strong organizational and critical‑thinking skills, including attention to detail.
• Travel required up to 25%.
• Must be capable of performing all clinical tasks relevant to licensure or training.
• Excellent written and verbal communication skills.
• Good interpersonal skills demonstrated through interactions with participants, Element staff, sponsor representatives, etc.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Availability, flexibility, and maturity to represent the company at community events and projects.
• Technical background is a plus.

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Element is one of the fastest‑growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to…