Clinical Research Coord III
Job no: 514753
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Department:29680300 - MD-CTSI-CLINICAL RESEARCH CNTR
Responsible for the administration of a subset of clinical trials and studies. Duties for this role include: assisting with screening and selection of study patients; obtaining informed consents; scheduling patient clinic visits as well as ancillary testing in house and off-site; completing Case Report Forms, coordinating the paperwork for IRB approval and HIPAA compliance; creating patient files (paper and electronic), maintaining and updating same. Ensure that subjects meet all inclusion criteria. Serve as liaison between family and research team. May coordinate multi-center studies that may involve supervision over other sites. Facilitate research or project team meetings. Performs self-monitor and self-audit responsibilities. Maintains regulatory binder for each protocol and ensures all regulatory documents are organized and kept appropriately.
Develops and analyzes clinical research activities for participants and makes changes in methods and procedures as necessary. Follows patient hospitalizations, clinic/office visits, treatments and scheduled activities. Performs clinical nursing procedures as permitted by current licensure. Assists with physicians on operations and orders for protocol tests, and follow-ups. Reviews lab results and inform PI of abnormal values. Communicates with patients or participants on a regularly scheduled basis. Assesses progress, evaluates problems and determines appropriate action or physician consultation as needed. Serve as liaison for research subject, family members, investigator, IRB, sponsor and healthcare professionals involved with the patients/participant’s care and follow-up status. Manages research specimen collection, storage or shipping for analysis. Manages tests, procedures and equipment per each protocol’s requirements. Participates in promoting Human Subjects Protections with Clinical Research Areas.
Educate and mentor clinical staff, research team and other coordinators. Educate staff on research projects and enrolling qualified subjects. Maintain and distribute instruction manuals to assist staff in managing patient eligibility for study and how to contact study investigators (s). Coordinate with investigational pharmacy regarding availability and randomization of medications for assigned protocols..
Support a PI sponsored Investigational New drug (IND) or Investigational Device Exemption (IDE). Host and prepare for external audits involving sponsor, FDA, NIH, etc. Assist in the quality assurance process. Serve as liaison for hospital billing for research participants and work with fiscal administrator to ensure proper invoicing for study tests and procedures for enrolled patients. Prepare study budget and may be involved in study contract negotiation.Expected Salary:
$65,000-$85,000 commensurate based on education and experience.Minimum Requirements:
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. Valid Florida nursing licensePreferred Qualifications:
Knowledgeable regarding IRB procedures, forms and approval process
Knowledge of nursing principles, practices and techniques
Knowledge of basic principles and good clinical practice of clinical research
Experience coordinating clinical research studies
skilled in the use of nursing equipment and instruments
Ability to collect, collate, analyze and evaluate data from clinical research studies
Ability to plan, organize and coordinate work assignments
Ability to work effectively and independently
Ability to communicate effectively, both verbally and in writingSpecial Instructions to Applicants:
In order to be considered, you must upload your cover letter and resume.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required:Yes
Advertised: 29 Sep 2020 Eastern Daylight Time
Applications close: 06 Oct 2020 Eastern Daylight Time