OverviewElement 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
Responsibilities- Leads a team of clinicians and technicians in carrying out complex study protocols:
o Management may include multiple concurrent studies
o Studies may require multiple visits by participants
o 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.
Skills / Qualifications- 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
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