Clinical Research Coord II
About The Position
Coordination and Patient Engagement Assist Principal Investigator with all study related duties Identification and Recruitment of subjects Communication with subjects via telephone, email, and/or in person to gather necessary research information, schedule appointments, remind subject of protocol requirements, and address questions and concerns Prepare and compile necessary items for research study appointments Schedule subject visits in the Clinical Research Center (CRC) and with other necessary clinic or ancillary offices Coordinate with Investigational Pharmacy for study visits requiring study drugs and arrange for orders and dispensing Obtaining Informed Consent Screening and obtaining accurate and complete medical history Documenting and maintaining accurate patient records Appropriately assess and document adverse events Dispensing Investigational products Documenting investigational product accountability Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols and GCP/ICH guidelines Obtain vitals and collect study samples Sample processing Study Regulatory Management This position must be familiar with current research protocol guidelines and assist with reviewing new protocols. Preparation of documents required for initial submission to UF research offices and for the sponsor. Preparing and submitting regulatory documents for revisions and continuing reviews. Development of recruitment and advertising materials Responsible for preparing reports for the Institutional Review Board in a timely manner Development of Informed Consent, incorporating UF required language and local regulations into consent templates Development of Source Documents Manage essential regulatory documents Filing source documents Data Entry/ Query Resolution per sponsor guidelines Facilitating sponsor/monitor visits Facilitate study closeout procedures Retain Records/Archive documents after closeout Financial Participate in development of study budgets Requesting Cost of Service from Ancillary departments Management of study billing plans (including OnCore entry) EPIC Charge Review of study subject billing Participate with finance team in the tracking and management of study finances including sponsor invoicing and resolving study subject billing issues Management of HSP payment tracking and compliance Other duties as assigned – not defined herein but associated with study management and integral to study team.
Requirements
- Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- Prior experience with clinical research.
- Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore)
- EPIC EMR System
Responsibilities
- Assist Principal Investigator with all study related duties
- Identification and Recruitment of subjects
- Communication with subjects via telephone, email, and/or in person to gather necessary research information, schedule appointments, remind subject of protocol requirements, and address questions and concerns
- Prepare and compile necessary items for research study appointments
- Schedule subject visits in the Clinical Research Center (CRC) and with other necessary clinic or ancillary offices
- Coordinate with Investigational Pharmacy for study visits requiring study drugs and arrange for orders and dispensing
- Obtaining Informed Consent
- Screening and obtaining accurate and complete medical history
- Documenting and maintaining accurate patient records
- Appropriately assess and document adverse events
- Dispensing Investigational products
- Documenting investigational product accountability
- Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols and GCP/ICH guidelines
- Obtain vitals and collect study samples
- Sample processing
- Assist with reviewing new protocols
- Preparation of documents required for initial submission to UF research offices and for the sponsor.
- Preparing and submitting regulatory documents for revisions and continuing reviews.
- Development of recruitment and advertising materials
- Responsible for preparing reports for the Institutional Review Board in a timely manner
- Development of Informed Consent, incorporating UF required language and local regulations into consent templates
- Development of Source Documents
- Manage essential regulatory documents
- Filing source documents
- Data Entry/ Query Resolution per sponsor guidelines
- Facilitating sponsor/monitor visits
- Facilitate study closeout procedures
- Retain Records/Archive documents after closeout
- Participate in development of study budgets
- Requesting Cost of Service from Ancillary departments
- Management of study billing plans (including OnCore entry)
- EPIC Charge Review of study subject billing
- Participate with finance team in the tracking and management of study finances including sponsor invoicing and resolving study subject billing issues
- Management of HSP payment tracking and compliance
- Other duties as assigned – not defined herein but associated with study management and integral to study team.
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What This Job Offers
Career Level
Mid Level
