Lead Clinical Research Coordinator - 258495

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

Job summary

Medix seeks an experienced Lead Clinical Research Coordinator to build and lead a growing program at our Phoenix site. You will own day-to-day operations from SSU through closeout, mentor CRCs, and collaborate with a physician new to clinical research.

You will manage participant interactions, regulatory and CTMS processes, and sponsor communications to ensure compliant, high-quality studies while maintaining a patient-centric experience.

Qualifications

• 3+ years in clinical research coordinating complex protocols
• Experience managing studies from site start-up through closeout
• Strong understanding of ICH-GCP, FDA requirements, and study protocols
• On-site work Monday–Friday, 9:00 AM–5:00 PM

Responsibilities

• Independently manage studies from SSU through closeout per protocol
• Primary contact for participants, sponsors, and the research team
• Coordinate and conduct visits, screenings, enrollment, and procedures
• Perform phlebotomy and EKGs as needed
• Prepare for participant visits with required docs and materials
• Maintain eSource documentation and accurate study records
• Ensure regulatory files are audit-ready and compliant
• Support sponsor monitoring visits and audits
• Mentor and train CRCs as the department grows
• Set up efficient workflows for the new research department

Skills

Independent ownership

Regulatory knowledge

ICH-GCP FDA familiarity

On-site work

Tools

CTMS

eSource

EMR systems

Job description

Lead Clinical Research Coordinator (CRC)

Location: Phoenix, AZ (85050)

Pay: $35 - $45/hour

Schedule: Monday-Friday, 9am-5pm

Overview:

We are seeking an experienced Lead Clinical Research Coordinator (CRC) to help build and lead a growing clinical research program. This is a high-autonomy, hands-on opportunity for a CRC who is ready to take ownership of a site’s day-to-day research operations while growing into a future management role.

As the foundation of a new research department, you’ll have the opportunity to truly build the program from the ground up. You’ll manage studies from site start-up through closeout, serve as the primary point of contact for participants, sponsors, and the research team, and work closely with a physician who is new to clinical research. As the department grows, you’ll have the opportunity to mentor and eventually help build a team of CRCs.

This role is ideal for someone who enjoys wearing multiple hats, working independently, and being the person who knows the ins and outs of every study. Rather than simply following processes established by a large research organization, you’ll have the autonomy to shape how the research program operates and help set it up for long-term success.

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.

Qualifications:

• 3+ years of experience as a Clinical Research Coordinator managing 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.

Preferred:

• Proficiency in phlebotomy.
• Experience performing EKGs.
• Previous experience working with or guiding research-naive Principal Investigators.
• Experience supporting or participating in sponsor or FDA audits.
• Experience mentoring or training other CRCs.
• Experience with CTMS, eSource, EMR systems, and electronic regulatory systems.