Clinical Research Coordinator Level 1

Company Description

Radiance Clinical Research, formerly FMCScience, is a dedicated research facility in Lampasas, Texas. Located in Central Texas, the city connects to major highways in five directions and covers a service area of over 80,000 patients. Radiance Clinical Research is now under ownership of Lauren Atkinson Garner, Dr. Vanna Gold, and Mia Monroe Mann as of 15DEC2023. Radiance Clinical Research is proud and fortunate to offer clinical trials to residents of Lampasas, Georgetown, Copperas Cove, and Central Texas. We offer a wide variety of phase II-IV clinical drug and device trials. Radiance aims to be a positive force in the community and the surrounding area. We want to help boost the local economy and offer cutting-edge treatment options to our friends and neighbors. We strive to make a difference!

Role Summary

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, the CRO, the Sponsor, the monitor, and Radiance department staff, to conduct the clinical study in a quality and compliant manner.

During the conduct of a clinical study, the Clinical Research Coordinator reports primarily to the Principal Investigator with associated responsibilities to the RADIANCE clinical study team.

Responsibilities

• Ensuring the study conduct is compliant with applicable local and federal laws and regulations.
• Cooperates with RADIANCE staff and leadership to report and address instances of noncompliance and/or nonconformity.
• Coordinates and facilitates monitoring and auditing visits.
• Notifies RADIANCE staff and leadership of external audits by FDA and Sponsors.
• Collaborates with PI, RADIANCE staff and leadership to respond to audit findings and to implement approved recommendations.
• Collects documents needed to initiate a clinical study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Coordinates and conducts clinical study subject visits for the completion of protocol-specified study tests, assessments, and the collection/processing of requisite biological laboratory specimens.
• Collects all clinical study data as required by the protocol.
• Assures timely completion of Case Report Forms, source documents, and/or entry into electronic repositories/databases.
• Maintains study timelines.
• Maintains adequate inventory of clinical study supplies.
• Handles, manages and maintains investigational products (IP) in compliance with the clinical study protocol, applicable clinical study/pharmacy plans, Sponsor/CRO directives and/or RADIANCE IP Drug/Device accountability policies.
• And more

Qualifications

General

• Excellent written and verbal communication skills
• Superior organizational and time management skills
• Capable of working independently with minimal supervision and also as part of a team
• Skilled with standard computer programs including the MS Office suite
• Participate with staff, managers and/or corporate leadership in the creation and implementation of processes and procedures toward quality improvement initiatives
• 1+ years previous experience working in a clinical setting. A combination of education and related technical/paraprofessional experience may be an acceptable alternative.
• Motivated to learn and assume responsibility for advanced Clinical Research and associated supportive activities.
• Ability to effectively assist, under supervision of the assigned CRC, in the management and conduct of multiple projects.

Job Type: Full-time

Pay: $21.29 - $25.64 per hour

Expected hours: 36 – 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift

Ability to Relocate:

• Lampasas, TX 76550: Relocate before starting work (Required)

Work Location: In person