Medical Director (Clinical Research Physican)
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 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 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 Task and Responsibilities
- Serve as Principal Investigator or Sub-Investigator on FDA form 1572 for protocols conducted. The employee should anticipate having the Principal Investigator role on as many 16 protocols per calendar year
- 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 and informed consents for clinical studies
- Be available for communications with sponsor in regard to study progress
- 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
Additional Tasks and Responsibilities
- Review SOPs and assist with SOP revisions when applicable
- Assist in drafting Notes to File
- Identify QIs 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
- Active Medical Doctor or Doctor of Osteopathy License, State of Florida
- Minimum of five years of clinical research experience preferred
- 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, 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 email@example.com.