Clinical Research Coordinator (CRC/Phlebotomy experience)

Truvian Sciences•San Diego, CA

26d•$60,000 - $80,000•Onsite

About The Position

Truvian is a healthcare technology company developing an automated benchtop diagnostic platform that delivers laboratory-quality results in 30 minutes or less. The company has developed proprietary technology that has received FDA clearance and is designed to make blood testing more accessible, convenient, and affordable. Truvian is pursuing CLIA Waiver status to enable point-of-care testing. The company culture is dedicated to discovery and empowerment, aiming to put health information in the hands of individuals. This role is an onsite position supporting clinical study execution, serving as an in-house clinical operations lead. The role involves coordinating activities, maintaining regulatory documentation, and supporting donor visits. The Clinical Research Coordinator will work closely with the Clinical Development Team and other internal/external stakeholders to ensure studies comply with protocols, Good Clinical Practice (GCP), and FDA regulations. The role also requires hands-on phlebotomy experience as a qualified secondary phlebotomist for venipuncture and/or capillary collection. Occasional support for Research Associate staff, including testing with clinical laboratory instrumentation, may also be required. The position reports to the Clinical Studies Director.

Requirements

Minimum 3 years of experience working as a Clinical Research Coordinator (or equivalent clinical research role) at a clinical research site or medical device/biotech sponsor, including direct experience conducting participant informed consent and site-level study coordination.
Hands-on phlebotomy experience (venipuncture and/or capillary collection) for adult donors; CA state-licensed Certified Phlebotomy Technician (CPT I/II) preferred or ability to obtain certification.
Demonstrated clinical operations experience, including site management and regulatory documentation/TMF maintenance in compliance with Good Clinical Practice (GCP).
Strong working knowledge of GCP, FDA regulations (e.g., 21 CFR Parts 50, 56, 812), and HIPAA requirements applicable to IVD/device clinical studies.
Ability to work as a collaborative clinical research team member with positive, timely written and verbal communication, including communicating protocol deviations or issues with study execution.
Strong organizational and time-management skills, with the ability to manage aggressive timelines, prioritize appropriately, and maintain accuracy and completeness in all study documentation.
Experience with business and study management tools, including Microsoft Office products and Smartsheet or similar project tracking tools.
A solution-oriented, problem-solving approach and the ability to thrive in a fast-paced start-up environment.

Nice To Haves

CA state-licensed Certified Phlebotomy Technician (CPT I/II) preferred or ability to obtain certification.
A bachelor’s degree in life sciences preferred.
Certified Clinical Research Coordinator (CCRC) or equivalent certification is a plus.

Responsibilities

Proactively oversee the execution of internal clinical studies conducted at Truvian Headquarters, including recruitment of internal and external donors, data collection and entry, and maintenance of the Trial Master File (TMF)/site regulatory binders.
Maintain up-to-date study documentation, including Informed Consent Form (ICF) records, enrollment logs, specimen tracking logs, eligibility/screening records, deviation logs, and compensation logs, as applicable.
Maintain working knowledge of multiple IRB-approved protocols and ensure compliance.
Manage scheduling systems for available appointments, recruit and schedule donors, re-schedule as needed and perform reminder calls.
Work closely with internal teams to forecast sample needs for upcoming studies.
Maintain accurate donor compensation records and collaborate with Finance to resolve payout concerns, where applicable.
Improve existing systems or implement new systems to manage the above tasks as efficiently as possible.
Support Clinical Studies Director by conducting external site support activities, including assisting with Site Qualification, Site Setup/Site Initiation, Site Management, Interim Monitoring, and Close-Out activities, as needed.
Develop site forms and logs, track site readiness, gather essential documents, set up and maintain TMFs, manage site inventories and shipments, track site issues, and review site data.
Occasionally, travel to partner sites to assist with training/demonstrations.
Support primary phlebotomist as a qualified secondary phlebotomist, performing venipuncture and/or capillary collection for adult donors using standard straight needles and butterflies.
Proactively support primary phlebotomist with day-to-day activities, such as ordering phlebotomy room supplies, tracking expiration dates, and maintaining a clean, organized collection area, including oversight of decontamination and biohazardous waste disposal.
Work in the laboratory with Research Associates to support studies on Truvian and various clinical laboratory instrumentation, as needed.
Proactively identify and develop mitigations against anticipated study risks and obstacles.