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Lead Clinical Research Coordinator

OnLume Inc.
Madison, WI
  • Expired: January 22, 2022. Applications are no longer accepted.

About Us
OnLume Surgical is a Madison, WI based medical device company providing intuitive and ergonomic solutions for
precise fluorescence image-guided surgery. OnLume Surgical is committed to providing surgeons with critical
information on tissue types, features, and function in real-time during surgery through fluorescence.

With a love of people, science, engineering, and medicine, OnLume Surgical values life, and innovation. Fueled
by strong values, team members undertake each day the bold commercialization of novel fluorescence-guided
surgical imaging devices to advance surgical precision for the benefit of worldwide public health.
Fluorescence-guided surgery technology only scratches the surface of what is possible. The team at OnLume is
eager to show the world how their novel approach dramatically enhances surgical visualization and precision -
and can improve patient outcomes.

At OnLume Surgical, character, talent, and training are the building blocks of teamwork. OnLume Surgical is
looking for innovative, talented people who share the commitment to change the world of surgery through
accelerating the science and application of fluorescence imaging.

If you share the passion for getting up every day and making the world better through technology - then you
may just be the next team member for OnLume Surgical!

As a Lead Clinical Research Coordinator, you will partner with the VP of Research and assume primary
responsibility for assigned preclinical and clinical research projects and serve as liaison with participating
research sites.

Essential Job Duties and Responsibilities:
With direction, assume primary accountability for assigned preclinical and clinical research projects and
ensure compliance with applicable regulations, guidelines, and policies for study activities

Serve as liaison with participating research sites, including, but not limited to, physician investigators,
research nurses, and study coordinators

Manage and execute the overall project scope and timelines, coordinating with applicable cross-functional
teams (e.g., R&D, Operations) to identify goals and scope of clinical study projects

Lead research study start up and implementation activities (Includes creation of study binders, study logs,
work instructions, case report form, and other study related materials)

Develop and maintain documents such as research protocols, CRO/investigator agreements, and contracts

Facilitate, attend, and contribute to all key study meetings, including planning and training

Facilitate the completion of database development, statistical analysis, and study report writing

Function as a resource for trial sites for all study-related issues, including site-related problem identification
and corrective/preventive solution development. Handles issues/complaints/suggestions from sites
efficiently and effectively to maintain customer satisfaction

Ability to train site personnel on study activities including investigational product usage, maintenance and
accountability, sample collection, data entry and query resolution

Oversight of Trial Master File and Essential Documents. Experience with electronic Trial Master Files
preferred.

Assist with data collection process including with process of ensuring site compliance, patient data integrity,
edit checks, query resolution, and resolving data management issues - experience with electronic data entry
preferred

Support the design, implementation, and evaluation of recruitment strategies for study participants and
ongoing monitoring of accrual rates

Contribute to preparation of reports and analyses reflecting study progress, enrollment trends and
appropriate recommendations and conclusions

Critical skills and abilities:

BS or MS in the life sciences, biomedical engineering, or similar field with 3+ years' experience as a Research
Coordinator or Clinical Research Associate, with skills and knowledge following US FDA/ICH and IACUC
guidelines

Experience in clinical research with knowledge of Good Clinical Practices and all applicable US regulations
governing clinical research

Strong interpersonal and organizational skills

Excellent communication skills, both oral and written

Ability to prioritize workloads and work independently while maintaining team focus

Ability to travel (<10% of the time)

Excitement to challenge and passion to thrive.


This Job Is Ideal for Someone Who Is:

Collaborative - enjoys passion-driven teamwork, both within the company and with collaborators

Self-motivated - enjoys working independently

Innovative - prefers working in unconventional and creative ways

OnLume Inc.

Address

Madison, WI
53717 USA

Industry

Healthcare

View all jobs at OnLume Inc.