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Element Materials Technology · 21 hours ago

Clinical Research Manager

Boulder County, CO

Full-time

Onsite

Mid, Senior Level

$100K/yr - $145K/yr

Element Materials Technology is a leading testing, inspection, and certification business with a global presence. They are seeking a Clinical Research Manager to oversee clinical trials of medical devices and health tech, ensuring compliance with protocols and managing a team of clinicians.

AerospaceBuilding MaterialIndustrial EngineeringInfrastructureMechanical Engineering

Responsibilities

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

Qualification

Registered Nurse LicenseClinical Research ExperienceMicrosoft ApplicationsTeam LeadershipOrganizational SkillsTechnical BackgroundCritical ThinkingCommunication SkillsInterpersonal Skills

Required

Must be a Registered Nurse with a current license in the state of Colorado

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

Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management

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