Job Description

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:

The Department of Medicine is seeking qualified applicants for a Clinical Research Coordinator II position as an integral member of the central study management team. This position will participate in all aspects related to coordination of clinical research across multiple specialties, working with Division investigators and the team to coordinate clinical studies within the Department. This includes management of multiple research studies with different schedules and deadlines, including investigator initiated, industry sponsored and government sponsored trials. These trials may be local or multi-centered. Responsibilities which include, but not limited to, recruitment of assigned trials, interacting with participants within the assigned trials, data collection and management, AE/SAE reporting, scheduling study required procedures, and working with Sponsor and CRO for data entry on case report forms or into a computerized database & UF OnCore data system. The ideal candidate will have experience meeting deadlines, keen attention to detail, protocol requirements, sponsor requirements, IRB deadlines and comply with the regulatory policies and procedures regarding human subject research.

Essential Function:

Coordination and Patient Engagement

• Alongside Principal Investigator, coordinates 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, interprets/educates subject of protocol requirements, and addresses questions and concerns
• Coordinates the preparation of necessary instruments and 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
• Performs screening and obtains accurate/complete medical history
• Documents and maintains accurate patient records
• Appropriately assesses and documents adverse events
• Dispenses Investigational products
• Documents investigational product accountability
• Monitors subjects enrolled in trials in accordance with medical and health management standards, study protocols and GCP/ICH guidelines
• Obtains 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
• Liaise with finance team for 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:

$53,000 - $64,000 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 resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes