Luminatemed

Senior Clinical Research Associate

Nashville, Tennessee, United States · Senior

Sponsorship not specifiedDetected 4 days ago

GCPClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchCommunicationCollaboration

About the role

Our development programs include enabling at-home lab draws and infusions, preventing peripheral neuropathy, and preventing hair loss caused by chemotherapy.
Working closely with our Director of Clinical Operations, you will be the main point of contact in ensuring clinical trial execution at the sites is operating in accordance with GCP and study timelines.

Collaborate with internal and external clinical teams to support all phases of clinical trials, including study start-up, site initiation visits (SIVs), trial execution, and close-out.
Perform weekly check-ins with clinical sites to track progress, address issues, and provide ongoing support.
Manage and maintain essential study documents in compliance with sponsor requirements, study-specific processes, and Luminate SOPs.

Bachelor's degree in Life Sciences or a related field.
Prior experience with Trial Master File (TMF) management
Prior experience and proficiency in utilizing Electronic Data Capture (EDC) systems
Willingness and ability to travel 30- 4 0% during active clinical trials period
We've proven our ability to bring technologies to patients, with several active clinical trials around the world.
Personal Attributes - The Ideal Candidate Is:
Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility for tasks.
Requirements - The Ideal Candidate Must Have:

Communicative: Proficient in written and verbal communication and collaboration skills.
You are able to identify appropriate communication channels for problems and concerns.
E xperience within biotech start-ups
Experience working for a Sponsor company
Experience in the Oncology therapeutic area.
Strong site relationship management skills
A passion for working in small, entrepreneurial environments where everyone wears multiple hats.
Don't have all of these requirements?

Act as the subject matter expert for Luminate Medical devices, serving as the primary point of contact between sponsor and site staff.
3 - 5 + years of hands-on experience with in the medical device and/or pharmaceutical industry
Deep understanding of GCP, ISO 14155, and FDA regulations for medical devices

You'll be hands-on with the devices and with managing clinical sites as a representative of the sponsor company

This listing is sourced directly from Luminatemed's careers page and normalized into a canonical job model.