Lead Clinical Research Coordinator

Lead Clinical Research Coordinator - MUST BE CURRENTLY IN OR NEAR PHOENIX, AZ 85044

Company: MACOA Health

Location: On-Site in Phoenix, AZ 85044

Employment Type: Full Time

Compensation: Competitive hourly or salaried rate commensurate with experience (estimated range: $55,000–$75,000/year) plus benefits.

Industry: Clinical Research / Professional, Scientific, and Technical Services

About MACOA-Health:

At MACOA-Health, we are committed to advancing healthcare through patient-centered, high-quality clinical research. We partner with leading sponsors and CROs to deliver innovative therapies across diverse therapeutic areas. Our collaborative culture emphasizes regulatory compliance, operational excellence, and above all, patient safety and care. We are seeking a Lead Clinical Research Coordinator (CRC) with 2–3 years of experience to join our growing team. This role is central to the day-to-day conduct of clinical trials at our site, ensuring protocol adherence, accurate data collection, and a supportive experience for our participants.

Key Responsibilities

• Study Conduct & Coordination
• Coordinate all aspects of assigned clinical trials, from screening through study close-out.
• Ensure compliance with ICH-GCP, FDA, and sponsor/CRO protocols.
• Conduct informed consent discussions with participants, ensuring comprehension and documentation per site SOPs.

Patient & Investigator Support

• Schedule and manage participant study visits, assessments, and follow-up.
• Collect and process biological samples, ECGs, and other clinical procedures as required.
• Maintain strong communication with investigators, participants, and study teams to support safety and adherence.

Data & Documentation

• Enter data into electronic data capture (EDC) systems in alignment with ALCOA-C standards.
• Resolve data queries and ensure CRFs/eCRFs are accurate and complete.
• Maintain source documents and essential records in audit-ready condition.

Regulatory Compliance

• Prepare, submit, and maintain regulatory documents for IRB/IEC submission, approval, and continuing review.
• Maintain and update the regulatory binder/eReg system, ensuring completeness and compliance with sponsor and federal requirements.
• Track and file safety reports, protocol amendments, updated Investigator Brochures, and informed consent forms.
• Ensure timely reporting of adverse events (AEs/SAEs) and protocol deviations per regulatory guidelines.
• Support site inspections, audits, and monitoring visits by maintaining inspection-readiness.

Site Operations

• Collaborate with investigators, site staff, and sponsor/CRO representatives to ensure trial milestones are achieved.
• Assist with feasibility, pre-study site qualification, and initiation visits.
• Contribute to recruitment and retention strategies for diverse participant enrollment.

Requirements

• Associate’s Degree or Bachelor’s degree in Life Sciences, Nursing, or related field, or equivalent clinical experience.
• Minimum of 2–3 years of experience as a Clinical Research Coordinator.
• Strong understanding of ICH-GCP guidelines, FDA regulations, and clinical trial conduct.
• Familiarity with IRB/IEC submissions and regulatory documentation.
• Phlebotomy or specimen handling experience.
• Excellent organizational and communication skills.
• Proficiency with EDC, CTMS, and Microsoft Office Suite.

Preferred Qualifications

• Bilingual in Spanish
• Certification as a Clinical Research Coordinator (ACRP-CCRC or SOCRA-CCRP).
• Experience across multiple therapeutic areas.
• Experience with eRegulatory systems.

Why Join MACOA-Health?

At MACOA-Health, you will be part of a collaborative, mission-driven team conducting clinical research that directly impacts patient health outcomes. We offer opportunities for professional growth, hands-on experience across multiple therapeutic areas, and flexible work arrangements when possible.

This position is ideal for a CRC ready to expand their regulatory and operational expertise, contribute meaningfully to advancing science, and work in an environment that values accuracy, compliance, and compassion.