Clinical Research Coordinator (CRC/Phlebotomy experience)

Responsibilities

Broadly, this role is responsible for site-level clinical operations, regulatory documentation, and coordination of ongoing internal and external clinical studies—including phlebotomy support—to support delivering Truvian’s diagnostic products into diverse, global end markets

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. Specific tasks may include:

Developing site forms and logs, tracking site readiness, gathering essential documents, setting up and maintaining TMFs, managing site inventories and shipments, tracking site issues, and reviewing 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 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

Preferred

CA state-licensed Certified Phlebotomy Technician (CPT I/II) preferred

A bachelor's degree in life sciences preferred

Certified Clinical Research Coordinator (CCRC) or equivalent certification is a plus

Benefits

Medical, dental, vision, EAP, paid life insurance, LTD, and 401(k) benefits

Flexible vacation

Kombucha and cold brew on tap, craft coffee, and a variety of healthy snacks

Onsite gym

Farm-to-table onsite restaurant with a 30% discount

Our mission is to provide unprecedented access to blood testing. We enable sustainable healthcare with accessible blood testing for a healthier you.

San Diego, California, USA

https://www.truvianhealth.com

Late Stage

Total Funding

$208.1M

Key Investors

GreatPoint Ventures,Wittington Ventures

7wire Ventures,TYH Capital,Wittington Ventures

GreatPoint Ventures

2024-07-17

Series D· $74M

2021-02-24

Series C· $105M

2019-11-20

Series B· $27.1M

Leadership Team

Dena Marrinucci

Chief Operating Officer (COO)

Recent News

BioSpace

Truvian Health Announces Strategic Alliance with Siemens Healthineers to Advance the TruVerus™ Blood Testing Platform

2026-10-01

Medical Device Network

Siemens Healthineers partners with Truvian to advance blood test platform

Qualifications

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 donors

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

CA state-licensed Certified Phlebotomy Technician (CPT I/II) preferred

A bachelor's degree in life sciences preferred

Certified Clinical Research Coordinator (CCRC) or equivalent certification is a plus

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.

Required skills

Clinical Research Coordination, Informed Consent, Phlebotomy, Clinical Operations, Site Management, Regulatory Documentation, Trial Master File (TMF) Maintenance, Clinical Practice (GCP), FDA Regulations, HIPAA, Microsoft Office, Smartsheet

Preferred skills

A bachelor's degree in life sciences preferred

Experience

3+ years