Clinical Research Coord II

University of Florida•Gainesville, FL

About The Position

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.

Requirements

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Prior experience with clinical research.
Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore)
EPIC EMR System

Responsibilities

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
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
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
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.