Screening Manager

Quotient Sciences: Molecule to Cure. Fast.

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.

Why Join Us

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.

The Role

• 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
  
  

Main Tasks And Responsibilities

• 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
  
  

Job Demands

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
  
  

The Candidate

• 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
  
  

Application Requirements

When 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 Inclusion

Quotient 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.