Screening Manager

Quotient Sciences•Miami, FL

23h•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. Because 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

Clinical Research experience preferred
Fluent in English/Spanish
Computer proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
Excellent communication and interpersonal skills
Attention to detail
Minimum BLS certified
Must be aged 18 years or over
Must not have been debarred by the FDA

Responsibilities

Overall responsibility and day to day oversight over all Screening activities and personnel, including volunteer recruitment
To comply & adhere to GCP guidelines and regulations as required of this role
To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards
To ensure subject safety at all times
Provides encouragement, support, positive reinforcement and job enrichment opportunities to direct reports by undertaking regular 1:1’s; objective setting and regular team meetings
Effectively manages screening nurse, technicians, volunteer recruitment and screening personnel to ensure smooth delivery of studies
Reviews protocols for understanding of recruitment and eligibility criteria
Attends initiation and protocol training meetings
Monitors overall subject recruitment activities and provides frequent updates to the Project Manager
Ensures advertisements are placed in advance of recruitment to avoid delays in enrollment. Works with Project Management to ensure paid advertisements are within study budget
Staffs screening activities efficiently and to ensure volunteer safety and data quality
Works with Clinical Scheduling Manager to ensure coordination of entire clinical team to maximize operational efficiency
Explains research study requirements and obtains proper informed consent from research volunteers. Ensures consents are completed prior to the performance of any screening activities
Ensures new versions of informed consents are utilized appropriately for further screening. Coordinates the timely re-consenting of subjects with the clinic staff if required on admission
Obtains thorough medical histories and documents findings according to SOPs and Good Clinical Practice; evaluates positive medical history responses for eligibility
Reviews lab requirements and procedures to ensure compliance with study protocols
Reviews abnormal results of screening tests with the Investigators and alerts candidates of results which need further medical evaluation
Reviews completed screening charts for completeness and conformity with protocol requirements. Reports and documents any clinical results or compliance issues which would lead to study exclusion
Ensures all members of screening and recruitment teams are fully trained and signed off in the relevant SOP/competency and protocol before working unsupervised or on a study
Ensures the timely delivery of screening charts to the clinic in advance of admission
Ensure compliance of Biomedical Waste Plan at the Screening Office
Hosts random inspections by the Health Department and reports outcome of inspection to Quality Assurance
Prepares monthly screening and recruitment KPIs
Assists with clinical activities at Screening and the overnight facility as required