Clinical Research Manager

Overview

Element has a current opening for a Clinical Research Manager to join their team in Louisville, CO. The role is full-time and involves acting 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. For more information about the lab, visit: EMT Louisville CO Lab Page.

Responsibilities

• Leads a team of clinicians and technicians in carrying out complex study protocols.
• Manages multiple concurrent studies, including those requiring multiple visits by participants and travel to other states.
• Understands protocol requirements and utilizes critical thinking skills to track study progress, assist in recruitment, and develop case report forms.
• Maintains and completes case report forms in agreement with source documentation and study protocols.
• Maintains clinical supply accountability for assigned trials and secures all sponsor-supplied devices and equipment.
• Communicates regularly with sponsors and executive management regarding study design recommendations, progress, status, mitigation strategies, and all aspects of the study from start to finish.
• Directly supervises employees involved in data analysis and clinical execution, managing their work, performance, and training.

Qualifications

• Registered Nurse with a current license in the state of Colorado. BSN preferred.
• 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%.
• Capable of performing all clinical tasks relevant to licensure and/or training.
• Excellent written and verbal communication skills.
• Good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc.
• Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook).

Skills

• Ability to independently perform and train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training.

Benefits

Pay Range: $100k-$145k DOE

Schedule

Full Time

Pay

$100k-$145k DOE

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally, they have more than 9,000 brilliant minds operating from 270 sites across 30 countries. They help customers ensure their products, materials, processes, and services are safe, compliant, and fit for purpose. They empower employees to take charge of their careers and reward excellence and integrity with growth and development. Industries worldwide depend on their care, attention to detail, and the accuracy of their work. Element is committed to diversity and inclusion, providing equal opportunities for all candidates.

Diversity Statement

At Element, they take pride in putting their people first. They are an equal opportunity employer that recognizes diversity and inclusion as fundamental to their Vision of becoming “the world’s most trusted testing partner.” They consider all applications objectively and without regard to the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.