US ~ Miami
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 Medical Director serves as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staff. She/he complies and adheres to Good Clinical Practice (GCP) guidelines and ensures subject safety at all times. Additionally, she will triage and support new opportunities and support the medical team as needed during conduct of trials.
Main tasks and responsibilities:
- Serves 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 performs and complies 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
- Supervises morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposes
- Supervises 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, reads ECG’s and reviews 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, licensed physician assistants/nurse practitioner, nurses and clinical staff
- Maintains familiarity with crash cart and emergency resuscitation procedures
- Schedules and participates in weekend and night medical on-call with at least two other Physicians (or Licensed PA, ARNP). The on-call schedule will be assigned on a “per week” basis beginning on Monday morning and lasting through the following Monday morning. “On-Call duties will also include hurricane (and other disaster) responsibilities whereby the Physician must be willing to reside in the clinic overnight if necessary for as many as two nights in a row
- Works an average of ½ day on weekend days on an average of every third to fifth 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
- Reviews completed data entry and signs-off completed study documentation in a timely manner including a careful review and sign-off of AE coding and CSR
- Participates in writing and editing of protocols and informed consents for clinical studies Is available for communications with sponsor in regard to study progress
- Is available for FDA inspections and Pharmaceutical Sponsor Audits
- Attends as many as four (4) investigator meetings of less than 3 days duration each in the continental United States if required for protocol initiation
- Recognizes 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
Other tasks and responsibilities will include:
- Reviews SOPs and assists with SOP revisions when applicable
- Assists in drafting Notes to File
- Identifies QIs and helps draft and implement CAPAs
- Attends department and sponsor meetings
- Assists in training new staff (other MDs and/or ARNPs/PAs) as necessary
- Gives educational lectures and participates in Mock Code training as necessary
The job may involve the following:
- Having to manage a range of tasks/issues simultaneously
- Strict and tight deadlines
- Very high concentration of work
- Working outside normal working hours
- Needing to respond to client demands
- Working in a hazardous environment with high requirement to follow safety procedures
- Five years clinical research experience including role as Principal Investigator with particular experience in first-in-human trials that have a broad experience in the design/conduct of a full range of Phase I studies.
- Formal training in clinical pharmacology or board certification in pharmacology with a breadth of knowledge on PD measures/procedures preferred not required
- Active Medical Doctor License, State of Florida, or ability to obtain such prior to start date
- Must not be debarred, disqualified, or restricted by the FDA or State of Florida
- Maintains BLS and ACLS certification
- Maintains CITI Program certification
- Board Certified in a medical sub specialty (cardiology, endocrinology, nephrology, gastroenterology, critical care, pulmonary, infectious disease, rheumatology) preferred but not required.
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.