Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Serve as Investigator or Sub-Investigator on Phase I, non efficacy, mainly healthy volunteer, protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staff
- Comply & adhere to GCP guidelines and regulations
- Ensure study data is collected in accordance with Good Clinical Practice (GCP) standards
- Ensure subject safety at all times
Main tasks and responsibilities will include:
- Serve as Principal Investigator (PI) or Sub-Investigator on FDA form 1572 for protocols conducted. The employee should anticipate having the PI role on as many 16 Phase I protocols per calendar year.
- As a PI you will review and comment on the study protocol, review and understand the Investigators Brochure (for investigational drugs) / SmPC (for licensed drugs) and understand and accept the risk-benefit evaluation for study subjects before protocol signature.
- Satisfactorily perform and comply with all responsibilities of a clinical investigator including, but not limited to those specified in the ICH Guidelines for Good Clinical Practice, FDA form1572, FDA Rules and Regulations and other Investigator’s obligations specified in pharmaceutical company protocols and contracts
- Supervise morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposes
- Supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes place
- Attends to adverse medical events
- Performs physical exams, read ECG’s and review laboratory data for protocols conducted
- Conducts screening examinations and reviews screening results as necessary to assemble qualified research participant cohorts according to protocol stipulations
- Works in concert with Senior Director of Operations and the Clinical Leads to provide supervision and organization of physician, sub-Investigators, nurses and clinical staff
- Maintain familiarity with crash cart and emergency resuscitation procedures
- Work an average of ½ day on weekend days on an average of every third week as necessary to provide proper medical supervision of protocols. This will be coordinated with the on-call schedule and a single compensatory weekday off will be provided for each weekend on-call
- Review completed data entry and sign-off of completed study documentation in a timely manner including a careful review and sign-off of AE coding and CSR
- Participate in writing and editing of protocols, informed consents, interim safety summary reports and final clinical study reports for clinical studies
- Be available for communications with sponsor in regard to study progress, including interim dose decision meetings.
- Be available for FDA inspections and Pharmaceutical Sponsor Audits
- Attend as many as four (4) investigator meetings of less than 3 days duration each in the continental United States if required for protocol initiation
- Recognize that a full work week may demand in excess of 50 hours and that work schedules will ultimately be determined by protocol schedules, as well as medical on-call responsibilities, medical emergencies and screening responsibilities
- Review SOPs and assist with SOP revisions when applicable
- Assist in drafting Notes to File
- Identify Quality Investigations and help draft and implement CAPAs
- Attend department and sponsor meetings
- Assist in training new staff (other MDs and/or ARNPs/PAs) as necessary
- Give educational lectures and participates in Mock Code training as necessary
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Active Medical Doctor or Doctor of Osteopathy License, State of Florida
- Previous clinical research experience preferred but not essential.
- Board Certified in a medical specialty
- Must not be debarred, disqualified, or restricted by the FDA or State of Florida
- Maintains BLS and ACLS certification
- Maintains CITI Program certification
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.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.