Clinical Research Coord I

Classification Title:

Clinical Research Crd 

Classification Minimum Requirements:

Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Job Description:

Conduct of Research
 Supports clinical conduct of research and perform these duties as needed.
 Reviews and develops a strong knowledge of the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
 Communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
 Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
 Conducts or participates in the informed consent process including interactions with the IRB, discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Seeks consent for legal representatives from critically ill participants’ families. Able to hold sensitive conversations regarding research participation for critically ill patients.
 Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
 Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
 Works with the research manager to manage the day-to-day activities of the study including problem solving, communication and protocol management.

Regulatory and IRB
 Prepare revisions and continuing reviews to the IRB for submission.
 Prepare serious adverse events log after review with the PI for IRB submission.
 Attend IRB meetings when assigned protocols from the Department of Emergency Medicine are scheduled.
 Review and comprehend the protocol and collaborate with the PI and research manager to prepare IRB and any other regulatory submission documents.
 Prepare other study materials as requested by the PI. These study materials include, but are not limited to the informed consent document, Form FDA 1572, financial disclosures, regulatory binder, study specific source documentation and other materials.

Executes various components of research studies to expand and enhance the competitiveness of existing Departmental research programs
 Coordinate with Principal Investigators (PI) and staff of the Department of Community Dentistry and Behavioral Science and collaborators in Emergency Medicine, Biomedical informatics and other departments, the local Institutional Review Board, and Research Administration and Compliance to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University of Florida and sponsoring agency policies and procedures.
 Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects.

Expected Salary:

$44,000 - 48,000/YR, commensurate with education/experience

Required Qualifications:

Bachelor’s degree in an appropriate area of specialization and one year of appropriate experience. Appropriate specialization areas including nursing, public health, and other health oriented degrees. One year prior experience with clinical research or experience working in acute care (emergency or critically care) populations is preferred.

Preferred:

Ability to plan, organize, coordinate work assignments
Knowledge of the principles and techniques of effective verbal and written communication Skill and knowledge with various computer programs
Knowledge in database management and survey programs such as Research Electronic Database   Capture (REDCap), Qualtrics, or similar
Ability to understand, interpret and apply applicable rules, regulations, policies, and procedures Ability to independently perform various administrative tasks
Ability to collect and organize data for scientific presentation and publication Ability to meet deadlines

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume. This is a time-limited position.

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

Health Assessment Required: Yes