Operations - QA Specialist

Title: Quality Assurance Specialist

Position: Full-Time, Hourly

Based at: TCR – All Sites

Position Summary: The Quality Assurance Specialist (QA Specialist) will be primarily responsible for entering clinical trial data while following GCP and ICH guidelines. The QA Specialist will enter accurate information, identify errors and inconsistencies in the data capture process, all while working within study timelines. The QA Specialist will develop and maintain good communication and working relationships with study personnel. Since this is primarily a customer contact position, it requires an outgoing, friendly personality and someone who enjoys working with a diverse population of people. This position requires strong computer skills.

Key Skills and Competencies:

• Time management and workflow prioritization
• Computer proficiency
• Customer Service
• Attention to detail
• Strong verbal and written communication

Primary Accountabilities:

· Timely data entry/query resolution in accordance with sponsor timelines.

· Collaboration with site clinical personnel.

· Collaboration with sponsor clinical research associates.

· Directs the investigator signature process.

· Prepares charts for sponsor monitoring visits.

General Accountabilities:

• Attends meetings and/or teleconferences related to the assigned study.
• Completes quality assurance check of all source documents at each visit.
• Inputs patient data into company systems.
• Greets and assists monitors during remote/onsite visits.
• Receives and reviews monitor letters and is proactive in resolving any issues noted.
• Attends meetings and/or teleconferences related to assigned study.
• Completes quality assurance check of all source documents at each visit.
• Oversees chart appearance and organizes source documents.
• Enters studies in Clinical Conductor (visits, windows, elements, etc.)

This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description, and other duties, as assigned, might be part of the job.

A person in this position must be highly organized, utilize excellent verbal and written communication, and be able to multitask. This position requires excellent time management, communication skills, and confidentiality. This position may require travel, lifting (up to 50 pounds), and sitting for extended periods.

This position requires adherence to Tribe Clinical Research’s Core Values as outlined:

· We are passionate about working for a GROWTH ORIENTED company.

· We exhibit a HUMBLE but CONFIDENT approach to work.

· We communicate what needs to be said RESPECTFULLY.

· We love serving others and WORKING TOGETHER for the greater good.

· We can take constructive feedback well and have a POSITIVE ATTITUDE even when the going gets tough.

Reporting Structure: QA Manager

Tribe Clinical Research is an Equal Opportunity Employer