Clinical Research Coord II

Classification Title:

Clinical Research Coordinator II

Job Description:

The Department of Medicine, Division of Cardiology is seeking a full time Clinical Research Coordinator II. This position supports our clinical trials and works under the direction of the Associate Director of Clinical Programs for the Cardiology Clinical Trials Division to oversee and maintain the regulatory affairs for the Cardiovascular Clinical Trials Program.

This requires a mature individual that is self-motivated and willing to collaborate with faculty, fellows, research staff, sponsors from private, state and federal agencies, and study patients. The Research Administrator I will help in developing and maintaining infrastructure for all grant related /clinical trials for the division. The incumbent must understand the strategic direction of the division.

Essential Functions;

Preparation and Maintenance of Research Regulatory for Divisions of Cardiology, Nephrology, and Rheumatology

a) Verify that all documents are prepared and formatted correctly for each trial in all 3 divisions.

b) Assists Investigators with the preparation and submission of studies to IRB/VA/WIRB/GCRC and other appropriate departments that may be involved in overseeing the research study. Is responsible for coordinating the distribution of paperwork approvals to all appropriate departments involved in overseeing the study.

c) Assists all divisions Investigators with the submission of all adverse event information to the IRB/WIRB and distribution of reports and IRB approvals to the appropriate personnel and other appropriate departments, if required. Assists the investigator with the reporting of serious and unexpected adverse events to UF IRB within 5 working days and within 10 days to WIRB.

Creates and maintains cumulative adverse event table for submission to IRB. Maintains adverse event filing system.

d) Makes corrections or alterations as necessary over the course of the study to any and all regulatory documents.

e) Maintains communications with IRB/VA/WIRB/GCRC and other appropriate departments regarding the status of pending and ongoing protocols as it relates to the regulatory aspects.

f) Prepares all necessary documentation required by each Study Sponsor and updates the documentation as necessary.

g) Works closely with the Study Coordinators and Study Sponsor for 3 division's personnel to ensure that all regulatory books for all studies are up to date and in order.

h) Performs quarterly review of paperwork to ensure completeness of regulatory paperwork.

i) Responsible for the preparation and processing of all paperwork for the Office of Clinical Trials for all 3 divisions.

General Duties

a) Train others within the regulatory area and research staff of all 3 divisions to use and enters study data into a computer database system.

b) Types and files all regulatory documents efficiently and appropriately.

c) Operates PC and high speed printers using necessary software to produce and maintain both hard copy and disk files including computer backup files.

d) Performs miscellaneous other clerical duties as required, such as filing, photocopying, and reference searches. Performs miscellaneous tasks as requested by immediate supervisor.

e) Coordinates the smooth running of the office during vacations or sick calls to ensure continued high level of activity in the Office of Clinical Trials.

f) Attend all IRB, HIPAA, and other training classes. Alerts supervisor, physicians, study coordinators and other appropriate personnel of important developments in protocol activity and new projects.

g) Monitor all active trial delegation logs and trainings for 3 Divisions for compliancy.

h) Manage Clinical trial closeouts for all 3 divisions and do and manage storage of the Trials data.

Expected Salary:

$45,000 - $59,262 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:

Knowledge of IRB/WIRB rules, regulations and requirements

Knowledge of humans subjects research

Ability to communicate effectively orally and in writing

Ability to work independently

Proficiency in WORD

Knowledge of EXCEL

Knowledge of Internet use

Ability to organize files and other records

Ability to compose and type letters, memorandums, and other written communication/documents

Ability to use correct spelling, punctuation and grammar

Ability to verify data for accuracy and completeness

Ability to establish and maintain effective working relationships with others

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