Lead Clinical Research Coordinator — Build & Lead Program

Medix; Phoenix (AZ); On-site; USD 48,000 - 62,000; Full time

Job summary

Medix in Phoenix, AZ is seeking a Lead Clinical Research Coordinator to build and lead a growing clinical research program. This high-autonomy role requires taking ownership of day-to-day operations while growing into a management position.

You will manage studies from SSU to closeout, serve as the primary contact for participants, sponsors, and the research team, and mentor a budding CRC team as the department expands.

Qualifications

• 3+ years of experience coordinating complex clinical research protocols beyond basic vaccine studies.
• Demonstrated experience managing studies independently from site start-up through closeout.
• Strong understanding of clinical research regulations, ICH-GCP, FDA requirements, and study protocols.
• Experience managing both clinical and regulatory components of clinical trials.
• Comfortable working independently and taking full ownership of site operations.
• Ability to work fully on-site Monday through Friday, 9:00 AM–5:00 PM.

Responsibilities

• Independently manage clinical research studies from site start-up (SSU) through closeout, ensuring all study activities are completed according to protocol, ICH-GCP, FDA regulations, and sponsor requirements.
• Serve as the primary point of contact for study participants, providing a welcoming, professional, and patient-centered research experience.
• Coordinate and conduct study visits, including participant screening, enrollment, follow-up visits, and study-specific procedures.
• Perform clinical procedures such as phlebotomy and EKGs as needed.
• Prepare for participant visits by ensuring all required documentation, supplies, and study materials are ready.
• Build and maintain eSource documentation and ensure study information is accurately captured.
• Maintain accurate and complete participant records, regulatory documentation, and essential study files.
• Manage study supplies and investigational products in accordance with protocol and site requirements.
• Utilize the CTMS and other study systems to document activities, track study progress, and maintain accurate records.
• Maintain regulatory files and ensure required documentation is complete, current, and audit-ready.
• Conduct ongoing quality checks of study data and documentation to identify and resolve discrepancies or gaps.
• Ensure study activities remain compliant with FDA regulations, ICH-GCP, protocols, and sponsor requirements.
• Support sponsor monitoring visits, audits, and other quality or compliance activities.
• Serve as a key resource in preparing the site for potential sponsor or FDA audits.
• Take ownership of study recruitment and enrollment efforts.
• Leverage the site's EMR and other available resources to identify and engage potential study participants.
• Communicate with prospective participants, answer questions, and guide them through the research process.
• Partner with the physician and clinical staff to increase awareness and understanding of clinical research opportunities.
• Help educate the broader practice through activities such as lunch-and-learns and research-focused training.
• Work closely with a research-naive Principal Investigator (PI), providing guidance and support as they develop their understanding of clinical research processes and requirements.
• Serve as the day-to-day research subject matter expert for the practice.
• Help establish efficient workflows, processes, and best practices for the new research department.
• As the team grows, mentor and train new CRCs and delegate responsibilities appropriately.
• Provide day-to-day guidance to the research team and help ensure studies remain on track.
• Take increasing ownership of higher-level site responsibilities, including sponsor relationships, study budgets, contracts, and operational planning.

Skills

Independent management

Regulatory knowledge

ICH-GCP

FDA requirements

Phlebotomy

EKG

On-site work

Client communication

Tools

CTMS

eSource

EMR systems

Job description

Medix in Phoenix, AZ is seeking a Lead Clinical Research Coordinator to build and lead a growing clinical research program. This high-autonomy role requires taking ownership of day-to-day operations while growing into a management position.

You will manage studies from SSU to closeout, serve as the primary contact for participants, sponsors, and the research team, and mentor a budding CRC team as the department expands.