29050700 - MD-ENDOCRINOLOGY

Clinical Research Coordinator III

The Department of Medicine, Division of Endocrinology is seeking a full time Clinical Research Coordinator III. This position is primarily responsible for coordination of clinical trials in the Endocrinology Division. The Clinical Research Coordinator III will assist the Principal Investigator with award proposals, feasibility studies, scope and budget negotiation with sponsors, project setup in UFIRST, OCR approval, IRB regulatory and compliance approvals, and protocol development and modification as needed. The Division of Endocrinology has a robust and growing clinical trial program which provides a necessary service to complex patients for whom standard treatment protocols have not worked; in addition to providing invaluable information to industry sponsors developing the next generation of treatments for these diseases.

Essential Functions;

Clinical Research Trials Coordination

• Coordinates research studies and special projects as directed.
• Support any PI sponsored Investigational New Drug (IND) or Investigational Device Exemption (IDE) Host/ prepare for external audits (sponsor, FDA, NIH, etc.)
• Study drug storage and dispensation in compliance with individual drug requirements and unit SOP’s
• Document investigational product (drug/device) accountability
• Monitoring of subjects enrolled in trials in accordance with protocols and ICH/GCP guidelines
• Patient assessment and care monitoring for changes and complications providing for appropriate physician-based care
• Review of laboratory results providing for physician input on abnormalities or referral for additional work-up.
• Participates in direct subject care via collection of vital signs, ECGs, FibroScans, concomitant medication, adverse events, as well as other protocol required procedures.
• Collect and process biospecimens.
• Provide appropriate patient teaching for protocol adherence and understanding of their underlying disease/disease management
• Accesses medical records from Epic for medical history as well as results on diagnostic studies, labs, surgical pathology, clinic notes, etc.
• Develops and analyzes Clinical Research activities for volunteer participants and makes changes in methods and procedures as necessary
• Liaison for hospital billing for research subjects
• Screen, recruit, and enroll research participants.
• Conduct and document Informed Consent process of study subjects
• Schedule subject visits and study procedures
• Monitor and audit studies research binders
• Liaison for research sponsors, central lab, and research participants
• Ensures the safety of research and laboratory
• Performs related duties as required or deemed appropriate to the accomplishment of the responsibilities and functions of his/her area.
• Responsible for assisting in the interpretation and implementation of policies and procedures as they apply to assigned areas of responsibility.  May recommend changes on policy/procedures as necessary.
• Comply with Institutional policies, SOPs and guidelines
• Must comply with federal, state, and sponsor policies
• Participates in promoting Human Subjects Protections within Clinical Research areas

Regulatory/Clerical

• Maintain working knowledge of current code of federal regulations (CFR), GCP/ICH guidelines and apply to clinical trials practice. 
• Coordinate essential regulatory documents and IRB continued reviews
• Development of source documents to meet the requirements of each study protocol
• Coordinate with finance team regarding management of HSP payments and subject visit tracking
• Facilitate study close out activities
• Retain records/archive documents after study close out

Data Entry

• Fills out source documentation and enters data in EDC
• Enters patient visits and procedures in UF’s OnCore Database
• EPIC documentation

$52,500 - $66,000 Annually

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

3+ years Clinical Trial experience
• Prior or current clinical trial experience
• Phlebotomy and sample processing experience
• Knowledge of Regulatory guidelines and IRB submissions
• Data entry Experience (InForm, Medidata, Rave, REDCap, Connect, and Oncore)
• Clinical Research Coordinator Certification

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.