Clinical Research Manager

Exova•Boulder County, CO

49d•$100,000 - $145,000•Onsite

About The Position

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

Requirements

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

Nice To Haves

Technical background is a plus

Responsibilities

Leads a team of clinicians and technicians in carrying out complex study protocols:o Management may include multiple concurrent studieso Studies may require multiple visits by participantso 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.