Research Associate II

Thermo Fisher Scientific•Atlanta, GA

About The Position

The Research Associate II supports clinical research operations by conducting patient-facing study procedures, processing samples, maintaining study documentation and supplies, and supporting regulatory compliance. The role may include running patient clinics, performing vital signs, height and weight measurements, electrocardiograms, phlebotomy, urine collection, subject walks, and safety monitoring. Under the general supervision of a licensed physician, the associate may also support sleep-disorder evaluations and testing by applying electrodes and sensors and following sleep laboratory procedures. Some duties may only be performed where permitted by local regulations and with appropriate qualifications, certification, or supervision. The position works in a laboratory and office environment and may involve occasional travel to site locations, including domestic and international travel. The associate is expected to maintain quality and accuracy, follow clinical and regulatory procedures, collaborate with patients and colleagues, and manage multiple tasks with limited guidance.

Requirements

  • Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
  • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years; an appropriate combination of education, training, and directly related experience may be considered.
  • Good medical terminology knowledge and ability to conduct vital-sign measurements.
  • Strong understanding of Good Clinical Practices and ability to learn and maintain working knowledge of FDA regulations and company/client SOPs and WPDs.
  • Strong organizational skills and flexibility to manage changing workloads and timelines and multiple tasks.
  • Thorough attention to detail for accurate and efficient data entry.
  • Strong interpersonal and customer-service skills, a positive attitude, and good oral and written communication.
  • Ability to work independently and as part of a team.
  • Strong English language and grammar skills.
  • Strong computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint) and basic understanding of clinical-trial database systems.
  • Strong analytical and data-management skills.
  • Ability to meet the physical and work-environment demands described, including frequent mobility, repetitive hand movements, and occasional crouching, stooping, bending, and twisting.
  • Regular and consistent attendance.

Responsibilities

  • Perform technical patient-clinic procedures, including vital signs, height and weight measurements, and electrocardiograms.
  • Explain tests and trial requirements to patients.
  • Perform phlebotomy.
  • Perform non-technical procedures, including urine collection, subject walks, and safety monitoring.
  • Support sleep-disorder education, evaluation, treatment, and follow-up under the general supervision of a licensed physician, including applying electrodes and sensors as applicable.
  • Prepare and calibrate equipment for testing.
  • Interact with patients during study visits and perform study-related procedures.
  • Conduct screening tests according to protocol requirements.
  • Work independently in the laboratory, process samples, and/or liaise with laboratories.
  • Manage or complete orders for clinical supplies.
  • Assist with or oversee accurate freezer logs, specimen labeling, and other documentation.
  • Obtain informed consent when permitted by country regulations.
  • Report quality incidents and participate in their investigation and resolution.
  • Provide administrative support as needed.
  • Follow COPs, SOPs, Good Clinical Practice requirements, and local regulations.
  • Train new staff.
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