Ref No.

ASC-2019

Location

US ~ Miami

Assistant Study Coordinator

Company Overview

Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

 

The Role

  • Collects biological samples, performs phlebotomy, vital signs and ECG’s in accordance with the specific activity schedule.
  • Tracks overall study event schedule and participant compliance.
  • To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards.
  • To ensure subject safety at all times
  • To provide support to the Study Nurse ensuring delivery of clinical studies on time and to a high quality by supporting and co-ordinating staff to maximize operational efficiency.

Main tasks and responsibilities

  • Responsible for collection of biological samples; e.g. urine, and sputum.
  • Responsible for drawing blood specimens (by venepuncture) according to the times specified in the study schedules.
  • Responsible for recording and maintaining records of blood draws and other biological specimen collections (per SOPs) via paper or electronic source. 
  • Assist with the proper labelling and preparation of blood collection tubes when indicated.
  • Assures that all necessary blood collection tubes, equipment and supplies are on the floor prior to blood draw time.
  • Support the Study Nurse by providing leadership, encouragement, support and positive reinforcement within the clinical team
  • Work with the Study Nurse within the team to ensure that all study paperwork and training (dose/protocol etc.) for the clinical team is accurate and in place for the study
  • Support the Study Nurse with study specific equipment set-up prior to first dose where applicable
  • Prepares the unit for any scheduled activities and upon completion removes all equipment and/or supplies from the floor.
  • Able to take and record accurate vital signs; recognize and report any abnormal vital signs.
  • Able to operate ECG machine and holter.
  • Promptly reports any study participant’s adverse event and/or lack of compliance to the Study Nurse Coordinator.
  • Must be familiar with proper phlebotomy and laboratory procedures in compliance with OSHA regulations, Good Clinical Practices and Quotient Sciences Operating Procedures.
  • Responsible for proper biomedical waste disposal procedures and schedules.
  • Responsible for reading and understanding all protocols and schedules.
  • Responsible for assisting in the recording and distributing of meals to study participants according to strict meal schedules.
  • Assures that the unit is kept clean and orderly at all times and removes any items not permitted from the floor.
  • Able to interact and maintain a professional demeanour with study participants during their inpatient stay.
  • Responsible for observing confidentiality practices regarding any protocols, subject information and/or any relevant industry information at all times. Assists with any other duties as assigned.

Other tasks and responsibilities will include:

  • Ensure clinical equipment is maintained in good working order
  • Proactively promote working in a safe and responsible manner at all times
  • Identify opportunities for change and assist with implementation of process change

Job Demands

  • The job may involve the following:
  • Strict and tight deadlines
  • Very high concentration of work

 

The Candidate

Qualifications and experience required for competent performance

  • Technical school phlebotomy training or Medical Assistant certificate.
  • Minimum two years of active phlebotomy experience preferred.
  • Required to have working knowledge of OSHA regulations and proper blood collection techniques (evaluable during employee orientation period).
  • High attention to detail
  • BLS certification

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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