Senior Clinical Research Coordinator

Job Title: Senior Clinical Research Coordinator

Position Type: Full-time

FLSA Classification: Exempt, salaried

Location: Chandler, Arizona

Position Summary

TrialSphere Corp. is seeking an experienced Senior Clinical Research Coordinator to independently manage assigned clinical trials from start-up through close-out. This position is responsible for study-level coordination, operational decision-making, sponsor/CRO communication, protocol implementation, subject visit oversight, regulatory readiness, and cross-functional workflow management.

 The Senior Clinical Research Coordinator is expected to exercise independent judgment in managing study priorities, identifying operational and compliance risks, resolving study-related issues, and ensuring assigned trials are conducted in accordance with protocol requirements, ICH-GCP, FDA regulations, sponsor expectations, and site SOPs.

 This is a senior-level position requiring strong clinical research experience, independent problem-solving, and the ability to manage multiple complex trials with minimal day-to-day supervision.

 Essential Duties and Responsibilities

The Senior Clinical Research Coordinator will:

Manage assigned clinical trials from start-up through close-out, including study activation, visit planning, subject flow, sponsor communication, monitoring support, and study close-out activities.

Independently prioritize daily, weekly, and study-level workflows based on protocol requirements, subject safety, enrollment goals, data deadlines, sponsor expectations, and site operational needs.

Serve as a primary operational contact for sponsors, CROs, monitors, vendors, laboratories, imaging partners, and internal site staff for assigned studies.

Review protocols, manuals, visit schedules, and sponsor guidance to determine operational requirements and implement appropriate site workflows.

Identify protocol, operational, recruitment, compliance, and data-quality risks and recommend corrective or preventive actions to management and/or the PI.

Evaluate subject visit requirements and coordinate resources needed for successful visit execution, including investigator availability, assessments, labs, imaging, investigational product, and participant stipends.

Oversee accurate and timely completion of source documentation, EDC entry, query resolution, regulatory documentation, and sponsor-required tracking.

Prepare for and support monitoring visits, audits, sponsor reviews, and inspections by ensuring assigned studies remain inspection-ready.

Train, mentor, and support junior CRCs, research assistants, students, or other team members involved in assigned trials.

Communicate study updates, enrollment barriers, protocol concerns, and operational needs to the Site Director and PI.

Escalate medical, eligibility, safety, PI judgment, or major business decisions appropriately while independently resolving routine and study-operational issues within the scope of the role.

Maintain compliance with ICH-GCP, FDA regulations, HIPAA, IRB requirements, sponsor requirements, and TrialSphere SOPs.

 Decision-Making and Independent Judgment

This position requires the ability to independently evaluate study priorities, determine appropriate operational workflows, resolve study-management issues, assess compliance risks, communicate with external study partners, and make recommendations affecting study performance and quality.

The Senior Clinical Research Coordinator is expected to use discretion and independent judgment in matters of significance related to study conduct, data quality, subject visit operations, regulatory readiness, and sponsor deliverables.

 Qualifications

Minimum 3–5 years of clinical research coordinator experience required.

Prior experience independently managing multiple interventional clinical trials required.

CNS, neurology, Alzheimer’s disease, migraine, movement disorder, or complex Phase II–IV trial experience preferred.

 Strong working knowledge of ICH-GCP, FDA regulations, informed consent, source documentation, EDC systems, monitoring visits, and IRB requirements.

Experience communicating directly with sponsors, CROs, monitors, vendors, and investigators.

Ability to work independently, prioritize competing deadlines, and identify operational or compliance risks.

CCRC, ACRP-CP, CCRP, or similar certification preferred but not required.

 Physical and Operational Requirements

Ability to work onsite in a clinical research environment.

Ability to interact professionally with research participants, caregivers, investigators, sponsors, monitors, and vendors.

Ability to use CTMS, EDC, eReg/eSource, eConsent, email, Microsoft Office, and sponsor portals.

Occasional schedule flexibility may be required based on subject visits, monitoring visits, sponsor deadlines, or study needs.

Equal Employment Opportunity Statement

TrialSphere Corp. is an Equal Opportunity Employer. Employment decisions are based on qualifications, experience, job performance, and business needs, without regard to any protected status under applicable law.