Clinical Research Coordinator

ChronicleBio; Menlo Park (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

ChronicleBio in Menlo Park, CA, is seeking a Clinical Research Coordinator to support day-to-day execution across our clinical research operations. The role combines participant management, phlebotomy and specimen handling, and IRB submissions and regulatory documentation, acting as the operational center of studies.

You will run participant visits end to end, draw blood, and ensure regulatory binders are audit-ready as we expand into interventional and IND-enabled trials.

Qualifications

• Two or more years of experience as a Clinical Research Coordinator or in a comparable clinical research role.
• Active phlebotomy certification and current, routine venipuncture experience.
• Experience preparing and submitting IRB packages, including amendments and continuing reviews.
• Working knowledge of GCP, ICH E6, and human subjects research regulations.
• Proven ability to execute visits in a protocol and to document deviations.
• Strong written documentation habits.

Responsibilities

• Serve as the primary point of contact for study participants across screening, enrollment, visits, and follow-up.
• Complete CRF and eCRF entry, resolve queries, and maintain audit-ready data quality.
• Track visit windows and timepoints to ensure participants stay within the study schedule.
• Maintain the regulatory binder, training records, and study files in inspection-ready condition.
• Prepare, submit, and track IRB submissions, amendments, continuing reviews, and closures.
• Perform venipuncture and coordinate specimen handling and transfer to the lab.
• Support start-up and close-out activities, including site file setup and vendor coordination.

Skills

Clinical research coordination

IRB submissions

GCP / ICH E6

Phlebotomy certification

IRB package preparation

Tools

EDC systems

eConsent platforms

eRegulatory binder tools

Job description

Job Title: Clinical Research Coordinator

Type: Full-Time

We are hiring a Clinical Research Coordinator to support day-to-day execution across our clinical

research operations. This is a broad, hands-on role with three core pillars: participant and study

management, phlebotomy and specimen collection, and IRB submissions and regulatory

documentation.

You will be the operational center of our studies. You will run participant visits end to end, draw

blood yourself, keep the regulatory binder audit-ready, and prepare and track IRB submissions

with our central IRB. You will also be the first in-person contact for many participants living with

severe, poorly understood chronic illness, several of whom have had difficult experiences with

the medical system. Patience, clarity, and reliability matter as much as technical skill here.

This role reports into clinical operations and works closely with our scientific, laboratory, and

regulatory teams. As our program mix expands from observational and biobank studies into

interventional, IND-enabled trials, the scope of this role will grow with it.

What You'll Do

Participant Management

• Serve as the primary point of contact for study participants across screening, enrollment,
• visits, and follow-up.
• Conduct eligibility screening against protocol inclusion and exclusion criteria, and
• maintain accurate screening and enrollment logs.
• Administer informed consent, including confirming participant comprehension of
• procedures, risks, and rights before any study activity begins.
• Schedule and coordinate visits, including remote and mobile collection logistics, and
• manage participant communications before and after each visit.
• Handle participant questions, concerns, and complaints with care, and elevate clinical
• or safety issues promptly and through the right channel.
• Administer protocol-specified assessments such as questionnaires, vitals, and functional
• measures.

Study Management and Protocol Compliance

• Execute visits per protocol, maintaining complete and contemporaneous source
• documentation for every participant interaction.
• Complete CRF and eCRF entry, resolve queries, and maintain data quality to audit-ready
• standards.
• Track visit windows, protocol-specified timepoints, and follow-up requirements so that no
• participant falls out of window.
• Identify, document, and report protocol deviations, and support root cause discussion
• and corrective action.
• Maintain the regulatory binder, delegation of authority log, training records, and study
• files in inspection-ready condition.
• Support study start-up and close-out, including site file setup, supply and equipment
• readiness, vendor coordination, and participant file archiving.
• Work to Good Clinical Practice standards across observational and interventional

Phlebotomy and Specimen Collection

• Perform venipuncture on study participants per protocol, including specific tube types,
• volumes, and order of draw. This is a required, routine function of the role, not an
• occasional backup duty.
• Manage specimen labeling, accessioning, chain of custody, and collection-to-processing
• timing to protocol specification.
• Perform basic specimen handling and pre-processing as needed, and coordinate
• handoff to the laboratory team.
• Recognize and respond appropriately to adverse participant reactions during or after
• collection, and document and elevate adverse events per protocol.
• Coordinate with our mobile phlebotomy vendor for remote collections, including kit
• readiness, scheduling, and sample receipt verification.

IRB and Regulatory

• Prepare, submit, and track IRB submissions, including initial submissions, amendments,
• continuing reviews, reportable events, and closures.
• Draft and maintain IRB-facing documents such as informed consent forms, recruitment
• and participant-facing materials, and protocol amendments, and route them through
• internal review before submission.
• Serve as the operational liaison to our central IRB and manage response timelines for
• queries and stipulations.
• Maintain version control across protocols, consent forms, and participant materials so
• that only current approved versions are in use at any site.
• Support compliance with HIPAA, 21 CFR Part 11 expectations, and internal SOPs, and
• help draft or revise SOPs as our study operations mature.

What You Bring

• Two or more years of experience as a Clinical Research Coordinator or in a comparable
• clinical research role, with direct ownership of participant visits, informed consent, and
• Required: active phlebotomy certification and current, routine venipuncture experience
• on human subjects. We will assess this directly during the interview process.
• Demonstrated experience preparing and submitting IRB packages, including
• amendments and continuing reviews, and managing IRB correspondence.
• Working knowledge of GCP, ICH E6, and human subjects research regulations.
• Proven ability to execute visits in compliance with a protocol and to recognize and
• properly document a deviation.
• Strong written documentation habits. You write clearly, you write it down the same day,
• and you do not leave gaps for someone else to reconstruct.
• Comfort working in a lab environment and following specimen handling procedures
• Judgment and composure with a medically complex and often severely symptomatic
• Ability to work independently in a small company where processes are still being built,
• and willingness to build them.

Nice to Have

• Experience supporting decentralized or hybrid study designs, including remote consent
• and mobile phlebotomy.
• Experience with biobank or specimen-intensive protocols.
• Experience with interventional or IND-enabled trials in addition to observational
• research.
• SOCRA or ACRP certification, or a clinical background such as MA, LVN, RN, or EMT.
• Exposure to ME/CFS, Long COVID, POTS, MCAS, dysautonomia, or other chronic
• multisystem conditions, clinically or personally.
• Familiarity with EDC systems, eConsent platforms, and eRegulatory binder tools.

Logistics: On-site in Menlo Park, CA. Participant visit schedules occasionally require early or