Screening Manager
Quotient Sciences•Miami, FL
•Onsite
About The Position
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.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
