Clinical Research Coord II

Job no:534395
Work type:Staff Full-Time
Location:Main Campus (Gainesville, FL)
Categories:Grant or Research Administration, Health Care Administration/Support
Department:29050800 - MD-INFECTIOUS DISEASES

Classification Title:

Clinical Research Coordinator II

Job Description:

The Department of Medicine, Division of Infectious Diseases and Global Medicine is seeking a full time Clinical Research Coord II. The position will involve execution of all components of research studies under the direction of the Research Manager. Perform all Clinical Research Coordinator (CRC) Core responsibilities as well as additional responsibilities detailed below for Clinical Research Coordinator II. Assignments to include more complex studies (examples include but are not limited to Multi-Center coordination, studies where subjects at greater risk, therapeutic intervention trials involving subjects with infectious diseases, and/or studies involving subjects with illness being treated with procedures that may result in adverse events.) This work also entails timely completion of data collection, storage, retrieval and assisting with data analysis. Coordinate all clinical research activities with minimal supervision.

Essential Functions;

Executes various components of the research study to ensure the outlined benchmarks are met
 Reviews and comprehends the research study aims, benchmarks and timeline
 Oversees activities of Research Coordinators I’s, OPS Staff and volunteers
 Organizes and manages communication related to study

Completes logistics management, study data collection, storage, retrieval, and interpretation
 Maintains study timelines
 Scheduling patient follow up surveys and interviews
 Scheduling oversight committee meetings at relevant research sites
 Tracking patient visits and the study activities required at each contact
 Maintains adequate inventory of study supplies
 Prepare advertising if needed
 Screening patients for inclusion and exclusion criteria
 Obtaining informed consent
 Resolves study subject billing issues.
 Retains all study records in accordance with sponsor requirements and University policies and procedures
 Registers participants in to the Oncore system
 Maintains effective and ongoing communication with sponsor, research participants, research manager and PI during the course of the study.
 Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Regulatory document preparation and review
 Regulatory Binder and/or electronic Trial Master File (eTMF), Manual of Procedures (MOP), study specific source documentation and other materials
 Study guides and worksheets
 Licenses, which must be annually updated for members of the study team
 Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Coordinates monitor and oversight visits
 Scheduling oversight committee and monitoring visits/meetings
 Making sure all source documents are available
 Handling queries and edit requests promptly and courteously
 Working as the liaison between the, administration, IRB and all other departments relative to the study

Completes and manages start up materials (IRB, Ceded IRB’s, OCR, IDS)
 IRB/cIRB submission packet, including protocol, and consents
 IRB/cIRB and Sponsor correspondence, including IND, DSMB and site reports
 OCR application and correspondence
 Creates and maintains studies in Gatortrac’s
 IDS application and correspondence

Attends study related meetings and other specified tasks

Expected Salary:

$46,000 - $60,500 Annually

Minimum Requirements:

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

Preferred Qualifications:

Three years of experience in clinical trials or relevant human subjects research
Clinical Research Professional Certification (CRPC) or able to qualify for CRPC
Good Clinical Practice (GCP) and IATA certified
Experience using OnCore and Epic
Experience working in a clinical setting
Experience working within UF’s clinical research system
Experience working in REDCap
Experience working in Electronic Data Capture (EDC) systems
Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
Coordinates multiple tasks and work independently and productively in a fast paced, deadline-oriented environment.
Able to work collaboratively, forward ideas as appropriate and problem solve when needed.
Multi-media capabilities strongly preferred; proficiency with Microsoft Office such as Word, PowerPoint and Excel.
Ability to plan, organize, coordinate work assignments
Ability to meet deadlines

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

Salary : $46,000 - $60,500