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 manage 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.
• Studies may require multiple visits by participants.
• Studies may require 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 recruitment team by communicating screening goals.
• Creates case report forms, based on written protocol.
• Develops, completes, and maintains source documents.
• Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File.
• Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols.
• Assures clinical supply accountability for assigned trials.
• Responsible for securing all sponsor-supplied devices and equipment.
• Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish.
• Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

• Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred.
• Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training.
• Must not have any 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 is required up to 25%.
• Must be capable of performing all clinical tasks relevant to licensure and/or training.
• Must possess excellent written and verbal communication skills.
• Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc.
• Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook).
• Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company.
• Technical background is a plus.

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…