Clinical Research Coordinator (CRC/Phlebotomy experience) at Truvian in San Diego, CA

Job description

• Truvian is looking for an experienced Clinical Research Coordinator (CRC) to support clinical study execution. This is an ONSITE position. In this role, you will serve as an in-house clinical operations lead—coordinating activities, maintaining regulatory documentation, and supporting donor visits at Truvian. You will work closely with the Clinical Development Team, as well as internal and external stakeholders, including Regulatory, Product Development, Quality, and CRO/vendor partners, to ensure studies are conducted in compliance with the protocol, Good Clinical Practice (GCP), and applicable FDA regulations. You will partner with the external clinical team to assist with setting up new clinical sites and ensure that operations are running smoothly.
• This role also requires hands-on phlebotomy experience, as you will serve as a qualified secondary phlebotomist for venipuncture and/or capillary collection for on-site donor visits. You will occasionally partner with our Research Associate (RA) staff to support study efforts, including testing with clinical laboratory instrumentation on an as-needed basis.
• If you want to deepen your knowledge of clinical studies, while working alongside experienced mentors—this role is for you. This role will report to the Clinical Studies Director.

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.
• Clinical Operations & Study Coordination – 70%
• 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.
• Phlebotomy (Secondary) – 20%
• 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.
• Cross-Functional Support – 10%
• 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.

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.
• A bachelor’s degree in life sciences preferred; Certified Clinical Research Coordinator (CCRC) or equivalent certification is a plus.
• 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.
• If you want to stand out, please include a cover letter.

Skills

Required

• Clinical Research Coordinator experience
• Good Clinical Practice (GCP)
• HIPAA
• Microsoft Office
• Written and verbal communication
• Solution-oriented problem-solving

Preferred

• Bachelor's degree in life sciences

Benefits

• Unique Growth Opportunity: Gain hands-on experience in operational role coordinating clinical studies at Truvian to generate data that substantiate the performance of Truvian’s breakthrough blood testing technology.
• Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.
• Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.
• Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.
• You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
• Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
• Flexible vacation
• Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
• Onsite gym
• Farm to table onsite restaurant including a 30% discount
• $60,000 to $80,000
• The salary range for this position represents the anticipated range for qualified candidates. Compensation decisions are based on a variety of factors, including relevant experience, skills, education, training, certifications, internal equity, market data, and business needs. The final compensation offered to a successful candidate will be determined based on these factors and the requirements of the role.