Clinical Scheduling Coordinator

Quotient Sciences•Miami, FL

8d•Onsite

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

Requirements

Experience in a similar role in a fast paced environment.
Excellent analytical skills.
High levels of attention to detail.
Ability to manipulate spreadsheets and databases to a high level.
Excellent organisational skills with the ability to prioritise effectively.
Proven problem solving skills.
Excellent communication and interpersonal skill.
Ability to respond quickly to business demands and react to changing circumstances.
Must be aged 18 years or over.
Must not have been debarred by the FDA.

Nice To Haves

Experience in a healthcare environment preferable.

Responsibilities

Timely and accurately create / update the Activity Schedule and timetables necessary to conduct clinical studies successfully.
Ensure thorough understanding of the clinical protocol’s schedule of events and staffing requirements.
Ensure operational efficiency and safety through correct allocation of appropriately skilled and qualified staff.
Comply & adhere to GCP guidelines and regulations as required of this role.
Thoroughly read and understand the clinical protocol and build a schedule of events/activities (Activity Schedule) in accordance with protocol requirements and internal SOPs.
Liaise with team members including Clinical Scheduler, Clinical Lead, Clinic Manager, Investigator, Database Programmer, Laboratory Lead, and Project Manager when building Activity Schedule.
Participate in protocol meetings to discuss requirements for the Activity Schedule (e.g., dose time, stagger interval, priority of assessments, non-standard activities, etc.).
Distribute each version of the activity schedule (draft and final) to the project team.
Deal and manage effectively any last minute or unexpected amendments to the Activity Schedule.
Ensure any revision to the final activity schedule is posted on the designated shared folder and changes communicated timely to appropriate project team members.
Provide administrative support to Clinical Leads as needed.
Assist with preparing and managing the clinical rota to ensure effective delivery of clinical studies.
Deal and manage effectively with queries arising from the rota from staff and relevant departments.
Deal and manage effectively any last minute or unexpected amendments to the scheduled rota to ensure absence/sickness or activity level changes do not impact on effective delivery of studies or impact on volunteer safety.
Keep clinical senior management informed of all problems and developments regarding the clinical rota.
Identify desirable changes or modifications to the Scheduling program, which will enhance or improve the scheduling process.
Undertake other duties from time to time to contribute to the effective management of the clinical rotas.
Perform study related tasks within scope of training/qualification.