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 DemandsThe 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 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.
