Clinical Research Coordinator

Axentra Bio; San Diego (CA); On-site; USD 70,000 - 105,000; Full time

Job summary

Axentra Bio is seeking a Clinical Research Coordinator to manage clinical trials at the site level. This role is essential for ensuring compliance and quality standards in clinical research activities while engaging with patients and other stakeholders. Ideal candidates will have a background in life sciences and experience coordinating research studies.

Qualifications

• Minimum 1–3 years of experience coordinating clinical research studies.
• Strong working knowledge of GCP, FDA regulations, and ICH guidelines.
• Current GCP training and IATA certification preferred or must obtain.

Responsibilities

• Coordinate clinical trials from initiation to close-out.
• Conduct informed consent discussions with participants.
• Communicate with IRBs, sponsors, and CROs regarding protocol submissions.

Skills

Interpersonal skills

Detail-oriented

Organizational skills

Education

Bachelor’s degree in a life science

Certification in clinical research (e.g., ACRP or SOCRA)

Tools

Microsoft Office Suite

EDC Systems

CTMS

eRegulatory systems

Job description

Direct message the job poster from Axentra Bio

Private Practice Phoenix, and Scottsdale, Arizona

Position Summary

The Clinical Research Coordinator (CRC) at Axentra Bio is responsible for coordinating and managing

clinical trials conducted at the site level in accordance with Good Clinical Practice (GCP), regulatory

guidelines, and sponsor protocols. This role involves direct interaction with patients, sponsors, monitors, and internal staff and plays a central role in ensuring accurate data collection, regulatory compliance, and the delivery of high-quality clinical research services.

Primary Responsibilities

• Coordinate all aspects of assigned clinical trials from initiation to close-out, including screening,

enrolling, and following study participants.

• Conduct informed consent discussions and ensure that participants are fully informed before

study procedures begin.

• Schedule and conduct study visits according to protocol timelines and requirements.

• Collect, record, and maintain accurate source documentation and Case Report Forms (CRFs),

whether paper or electronic (eCRFs), in compliance with protocol and regulatory standards.

• Communicate with Institutional Review Boards (IRBs), sponsors, and Contract Research

Organizations (CROs) regarding protocol submissions, amendments, and safety reports.

• Maintain and update the investigator site file (ISF) and regulatory binders in accordance with

ICH-GCP guidelines and sponsor expectations.

• Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs), and assist in

documentation and resolution.

• Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections.

• Manage investigational product accountability and ensure proper storage, handling, and

documentation of study drugs or devices.

• Train and supervise other study staff, including Research Assistants, if applicable.

• Liaise with patients, physicians, and clinic staff to ensure coordination of care during study

• Maintain study-specific logs, including enrollment, deviations, screen failures, and consents.

Axentra Bio Job Description: Clinical Research Coordinator

• Uphold patient confidentiality and data integrity at all times.

• Perform other duties as assigned to support ongoing clinical research activities and operational

needs.

Qualifications

• Bachelor’s degree in a life science, nursing, public health, or a related field required. RN, LVN, or

certification in clinical research (e.g., ACRP or SOCRA) is preferred.

• Minimum 1–3 years of experience coordinating clinical research studies at a site or sponsor

level.

• Strong working knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial processes.

• Excellent interpersonal skills and the ability to build rapport with patients and team members.

• Proficient in Microsoft Office Suite; experience with EDC, CTMS, and eRegulatory systems is a

• Detail-oriented, highly organized, and able to manage multiple trials and tasks simultaneously.

• Capable of working independently with minimal supervision and as part of a collaborative team.

• Current GCP training and IATA certification are preferred or must be obtained upon hire.

Working Conditions

This position involves working in a clinical research office or medical facility and may require extended

hours to accommodate patient visits, sponsor deadlines, or regulatory inspections. Occasional travel to attend training, investigator meetings, or off-site visits may be necessary.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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