Job Description

Job Summary

The Clinical Research Assistant provides administrative and operational support for clinical research studies conducted by the organization. This position assists with document management, regulatory submissions, scheduling, and other activities essential to the coordination and execution of clinical trials. Under the supervision of the clinical program manager, the Clinical Research Assistant ensures that study-related documentation is accurate, organized, and compliant with applicable regulatory standards. The role requires strong attention to detail, effective communication skills, and the ability to perform routine support tasks within established guidelines. This position supports Clinical Research Coordinators (CRCs), investigators, and the broader research team to facilitate efficient trial conduct.

Duties and responsibilities

• Assists with study start-up activities, including the collection, organization, and preparation of study-related documents.
• Assists in maintaining regulatory binders and trial master files in compliance with sponsor and institutional requirements.
• Schedules participant visits and coordinates appointment logistics with clinical staff and investigators.
• Assists in preparing and submitting Institutional Review Board (IRB) documents, amendments, and continuing reviews under supervision.
• Knowledge and understanding of the laws, regulations, ICH/GCP guidelines, and ethical principles that guide the practice of clinical research.
• Knowledge and application of all privacy and safety standards as they relate to job responsibilities, human research subjects, staff, and the general operation of the facility.
• Tracks participant enrollment, screening outcomes, and visit completion to support study progress.
• Assists in maintaining study-related logs and trackers, such as delegation logs, screening logs, and training logs.
• Enters data into sponsor portals, electronic data capture (EDC) systems, and internal databases, ensuring accuracy and timeliness.
• Provides logistical and administrative support during site initiation visits (SIVs), monitoring visits, audits, and inspections.
• Assist in the receipt, inventory, and shipment of study supplies and laboratory kits.
• Supports Clinical Research Coordinators (CRCs) and investigators in daily clinical trial operations, following established procedures and protocols
• Other duties and responsibilities as delegated by clinical program manager.

Direct Reports

• NA

EEO Statement

Arizona Center for Cancer Care provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Qualifications/Education Requirements

• General Education Diploma or higher required, associate or bachelor’s degree in healthcare, life sciences, or a related field preferred.
• Prior experience (approximately one year) in a clinical research or healthcare setting preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Must complete GCP (Good Clinical Practice) training and hold a certificate of completion within 30 days of hire (required).

Licensure and Certifications

• Current CPR

Working conditions

• Works in an office or clinical setting.
• Exposed to moderate noise levels.
• Emphasizes collaboration with various stakeholders.
• Necessitates effective communication and teamwork.
• Functions in a fast-paced environment.
• May require flexibility in working hours.
• Requires adherence to safety protocols and compliance with healthcare regulations.
• Valid driver’s license and reliable transportation for travel between locations.

Physical requirements

• Must be able to lift 25 lbs.
• Must be able to sit, stand and walk for extended periods of time
• Must be able to bend, kneel, crawl and twist as needed
• Must be able to see, hear, type, and speak
• Must be able to reach and pull

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