Principal Investigator

Principal Investigator/Medical Director Opportunity at Quotient Sciences – MiamiQuotient 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.An excellent opportunity for a Principal Investigator/Medical Director to join Quotient Sciences – Miami, a dedicated, state-of-the-art, clinical pharmacology facility.The Miami site specializes in phase I clinical pharmacology studies with a proven track record of almost a thousand studies over the past 25 years. With 144 beds and a large recruitment database of 20,000 healthy volunteers, we're known for being able to rapidly start up new studies in record time and complete studies quickly with full cohorts of subjects.Join us as a Principal Investigator/Medical Director and help us to develop new medicines and get them to patients faster.The Role:Serve as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staffComply & adhere to GCP guidelines and regulationsEnsure study data is collected in accordance with Good Clinical Practice (GCP) standardsEnsure subject safety at all timesMain Tasks and Responsibilities:Serve as Principal Investigator or Sub-Investigator on FDA form 1572 for protocols conducted.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 contractsSupervise morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposesDirectly supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes placeAttends to adverse medical eventsPerform physical exams, read ECG's and review laboratory data for protocols conductedReview screening results as necessary to assemble qualified research participant cohorts according to protocol stipulationsWork in concert with site and Clinical Operations to provide supervision and organization of physician, sub-Investigators, nurses and clinical staffMaintain familiarity with crash cart and emergency resuscitation proceduresParticipate in on-call rotationReview completed data entry and sign-off of completed study documentation in a timely manner including a careful review and sign-off of adverse assessments, study interim summaries, as well as clinical study reportsParticipate in writing and editing of protocols and informed consents for clinical studiesBe available and participate in communications with sponsor in regard to study progressBe available for FDA inspections and Pharmaceutical Sponsor AuditsAdditional Tasks and Responsibilities:Review SOPs and assist with SOP revisions when applicableAssist in drafting Notes to FileIdentify quality issues and help draft and implement CAPAsAttend department and sponsor meetingsAssist in training new staff (other MDs and/or ARNPs/PAs) as necessaryGive educational lectures and participates in Mock Code training as necessaryThe Candidate:Active Medical Doctor or Doctor of Osteopathy License, State of FloridaMinimum of five years of clinical research experience preferredBoard Certified in a medical specialtyMust not be debarred, disqualified, or restricted by the FDA or State of FloridaMaintains BLS and ACLS certificationMaintains CITI Program certificationJob Demands:The job may involve the following:Very high concentration of workStrict and tight deadlinesHaving to juggle a range of tasks/issues simultaneouslyWorking in a hazardous environment with high requirement to follow safety proceduresWorking outside normal working hoursNeeding to respond to client demandsApplication RequirementsWhen applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.Our Commitment to Diversity, Equity and InclusionQuotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.