Operations - QA Specialist

Parkside Medical Group | The Onyx Group•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 specialist enters accurate information, identifies errors and inconsistencies in data capture, and works within study timelines. The role develops and maintains effective working relationships with study personnel and involves frequent customer contact with a diverse population. Strong computer skills are required. The position requires organization, multitasking, excellent time management, strong verbal and written communication, and confidentiality. It may require travel, lifting up to 50 pounds, and sitting for extended periods. The position requires adherence to Tribe Clinical Research’s core values: being passionate about working for a growth-oriented company; taking a humble but confident approach; communicating respectfully; serving others and working together; and receiving constructive feedback with a positive attitude.

Requirements

  • Strong computer proficiency.
  • Strong verbal and written communication skills.
  • Customer service skills and an outgoing, friendly personality.
  • Attention to detail.
  • Time management and workflow prioritization skills.
  • Ability to stay organized and multitask.
  • Ability to maintain confidentiality.
  • Ability to lift up to 50 pounds, if required.
  • Ability to sit for extended periods.
  • Ability to travel, if required.

Responsibilities

  • Complete timely data entry and query resolution 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.
  • Complete quality assurance checks of source documents at each visit.
  • Input 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.
  • Perform other duties as assigned.
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