Clinical Research Monitoring (CRA)

Clinical Research Assistant

This will be an in-person position in Daytona Beach (Hybrid).

Position Summary

The Clinical Research Assistant (CRA) provides operational and participant support for clinical research studies conducted at the site. This position assists Clinical Research Coordinators (CRCs), investigators, and study teams with participant scheduling, specimen processing, investigational product accountability support, supply management, and study-related documentation. The Clinical Research Assistant plays a critical role in ensuring efficient study conduct while allowing coordinators to focus on protocol management, participant care, and study execution.

Essential Responsibilities

Participant Support and Scheduling

Coordinate participant appointments and study visits.

Contact participants regarding upcoming visits and study requirements.

Assist with visit preparation and participant flow.

Maintain study calendars and visit schedules.

Support participant retention activities.

Study Operations

Maintain research supplies and study materials.

Order study-related supplies and equipment as directed.

Monitor inventory levels and maintain adequate stock.

Track expiration dates of study supplies and research materials.

Ensure study materials are organized and readily available.

Specimen Processing and Shipping

Process biological specimens according to protocol requirements.

Prepare and package specimens for shipment.

Complete shipping documentation and laboratory requisitions.

Maintain specimen shipment records.

Coordinate with central laboratories and couriers.

Study Documentation and Logs

Maintain temperature logs and equipment monitoring records.

Maintain medication accountability logs and inventory documentation.

Assist with essential study documentation.

Ensure logs are completed, accurate, and up to date.

Support filing and organization of study records.

Regulatory and Administrative Support

Assist with document collection and filing.

Route study documents for review and signature.

Support maintenance of regulatory binders and electronic regulatory systems.

Assist with study start-up and close-out activities.

Quality and Compliance

Follow protocol requirements, GCP, sponsor requirements, and site SOPs.

Escalate protocol deviations, equipment issues, or documentation concerns.

Participate in training and quality improvement activities.

Maintain confidentiality of participant and study information.

Qualifications

Education

High School Diploma required.

Associate's or Bachelor's degree in health science, biological science, or related field preferred.

Experience

Current or previous Pharmacy Technician experience is required.

Experience handling specimens or laboratory procedures preferred.

Knowledge, Skills, and Abilities

Strong organizational skills.

Ability to manage multiple priorities.

Attention to detail and accuracy.

Strong communication and customer service skills.

Ability to work independently and within a team environment.

Proficiency with Microsoft Office applications.

Ability to learn CTMS, EDC, and sponsor systems.

Physical Requirements

Ability to stand, walk, and move throughout clinical areas.

Ability to lift and transport study supplies and specimen shipments up to 25 pounds.

Ability to perform repetitive computer-based tasks.

#J-18808-Ljbffr