Job description:
Company: MACOA Health
Location: Phoenix, AZ Onsite
Employment Type: Full Time
Compensation: Competitive hourly or salaried rate commensurate with experience (estimated range: $55,000–$80,000/year)
Industry: Clinical Research
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.
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 1-2 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.
Job Type: Full-time
Benefits:
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Education:
Experience:
Location:
Phoenix, AZ 85044 (Required)
Ability to Commute:
- Phoenix, AZ 85044 (Required)
Job Type: Full-time
Pay: $55,000.00 - $85,000.00 per year
Experience:
- Clinical research: 1 year (Required)
Location:
- Phoenix, AZ 85044 (Required)
Ability to Commute:
- Phoenix, AZ 85044 (Required)
Work Location: In person