Operations - QA Specialist

Tribe Clinical Research•Greenville, SC

About The Position

The Quality Assurance Specialist is primarily responsible for entering clinical trial data in accordance with GCP and ICH guidelines. The role requires accurate data entry, identification of errors and inconsistencies in data capture, and work within study timelines. The specialist develops and maintains effective working relationships with study personnel. As a primarily customer-contact position, it calls for a friendly, outgoing approach and comfort working with a diverse population. Strong computer skills, organization, communication, time management, multitasking, and confidentiality are required. The position may require travel, lifting up to 50 pounds, and sitting for extended periods. The specialist reports to the QA Manager and is expected to adhere to Tribe Clinical Research’s Core Values.

Requirements

Computer proficiency and strong computer skills.
Strong verbal and written communication skills.
Excellent time management and ability to prioritize workflow.
Attention to detail.
Customer service skills and an outgoing, friendly manner.
Ability to work with a diverse population and collaborate with study personnel.
Strong organization and multitasking abilities.
Ability to maintain confidentiality.
Ability to lift up to 50 pounds and sit for extended periods; travel may be required.

Responsibilities

Complete timely data entry and resolve queries in accordance with sponsor timelines.
Collaborate with site clinical personnel and sponsor clinical research associates.
Direct the investigator signature process.
Prepare charts for sponsor monitoring visits.
Attend meetings and teleconferences related to assigned studies.
Perform quality assurance checks of source documents at each visit.
Enter patient data into company systems.
Greet and assist monitors during remote and onsite visits.
Receive and review monitor letters and proactively resolve issues noted.
Oversee chart appearance and organize source documents.
Enter studies in Clinical Conductor, including visits, windows, and elements.