Clinical Research Coordinator II (CRC II) – Contractor
About The Position
Axsendo Clinical Research is a community-focused clinical research organization committed to expanding access to high-quality, industry-sponsored clinical trials. We partner with community-based practices to deliver studies on time and on budget—while accelerating time to market and increasing representation in clinical research. Our mission is to extend research access into under-served and historically underrepresented communities, empowering patients with high unmet medical needs to participate in clinical trials that improve health outcomes. Axsendo supports sponsors in diversity planning and the development of effective community engagement strategies. We are building a research model centered on operational excellence, regulatory integrity, and trusted physician–patient relationships. The Clinical Research Coordinator II (CRC II) is a senior-level research professional responsible for independently managing multiple interventional clinical trials under the direction of the Principal Investigator (PI). The CRC II demonstrates strong operational ownership, regulatory fluency, and the ability to execute complex protocols with minimal oversight. This role requires a dependable self-starter who brings excellence, focus, accountability, and consistent follow-through to daily site operations. The CRC II will serve as a key driver of study timelines, enrollment performance, regulatory readiness, and participant experience. The ideal candidate thrives in a performance-oriented clinical research environment and takes pride in delivering high-quality work with precision and integrity. This position reports to the Director of Clinical Operations.
Requirements
- Bachelor’s degree in Biology, Nursing, or other healthcare-related field strongly preferred
- Minimum 2+ years of clinical research experience, including independent coordination of interventional trials
- Demonstrated expertise in ICH-GCP guidelines and regulatory compliance
- Experience managing moderate- to high-enrolling studies with minimal supervision
- Proven experience preparing regulatory submissions, maintaining essential documents, and ensuring audit readiness
- Strong competency in identifying, documenting, and reporting AEs, SAEs, and protocol deviations
- Dependable, accountable, and highly organized
- Self-starter with strong initiative and execution discipline
- Demonstrates excellence in work quality, attention to detail, and follow-through
- Strong time management skills and ability to prioritize competing demands
- Clear and confident communicator with sponsors, CROs, investigators, and participants
- Comfortable operating in a fast-paced, growth-focused research environment
- Must provide a minimum of two professional references
- Ability to lift approximately 20 pounds and stand for extended periods
Nice To Haves
- Licensed Registered Nurse (BSN) highly desirable
- CCRC or CCRP certification preferred (or willingness to obtain within 12 months)
- Experience in vaccine, cardiovascular, respiratory, device, or other complex therapeutic areas strongly preferred
- Clinical skills including phlebotomy, specimen processing, ECGs, vital signs, and participant assessments preferred
- Bilingual (Spanish-speaking) candidates strongly preferred
- Some travel in and around the Phoenix area may be required based on study needs
Responsibilities
- Ensure compliance with ICH/GCP guidelines and applicable local/state regulations
- Maintain and organize essential regulatory documents and study files
- Track study activities to ensure adherence to SOPs, protocols, and institutional policies
- Prepare for and participate in sponsor and CRO audits/inspections
- Identify and appropriately report adverse events (AEs), serious adverse events (SAEs), protocol deviations, and unanticipated problems
- Support feasibility assessments for sponsor-initiated studies
- Assist with site start-up activities including regulatory submissions and study activation
- Coordinate and lead pre-study, site initiation, monitoring, and close-out visits
- Serve as primary site contact for sponsors and CROs
- Coordinate participant screening, informed consent, and study visits per protocol
- Support recruitment initiatives, including educational and outreach materials
- Serve as a trusted point of contact for study participants
- Monitor enrollment progress and implement recruitment strategies as needed
- Collect, process, and manage study specimens (phlebotomy and sample processing preferred)
- Ensure accurate and timely data entry into EDC and other clinical systems
- Manage investigational product accountability, storage, and shipment
- Coordinate laboratory and diagnostic testing, ensuring timely review and reporting
- Provide regular updates to the Principal Investigator and site leadership
- Maintain study supply inventory and coordinate ordering as necessary
- Participate in Investigator Meetings, trainings, and ongoing professional development
- Support risk identification, mitigation planning, and operational improvements
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
