Clinical Research Coord II

Classification Title:

Clinical Research Coordinator II

Classification Minimum Requirements:

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Job Description:

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.

Expected Salary:

$51,000 - 61,000/annually 

Required Qualifications:

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Preferred:

Prior experience with clinical research. 
Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore)
EPIC EMR System

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

This position is time-limited. Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes