Clinical Research Coord III
Job no: 514652
Work type: Staff Full-Time
Categories: Research/Scientific/Grants, Health Profession
Department:29200000 - MD-RADIATION ONCOLOGY
Clinical Research Coordinator IIIJob Description:
20% Monitors study to ensure sponsor and investigator obligations are being met and are compliant with the protocol, monitoring plan, IRB, DISC, and UF standards, guidelines and policies, applicable regulatory requirements FDA, CRF, ICH, and GCP guidelines. Requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate regulatory requirements.
20% Reviews informed consent forms for compliance. Ensures that patients enrolled meet the study specific inclusion and exclusion criteria. Reviews data entry in the data management system for consistency with the subject’s electronic medical record. Performs source document verification.
20% Monitor patient safety by reviewing SAEs, AEs, (Serious Adverse Events, Adverse Events) unexpected problems. Document and inform study team of any items that were not appropriately reported. Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures.
20% Assists external sites/study teams with audit preparation.
15% Works closely with study team members to ensure timely resolution of study and/or clinical monitor findings; documents resolution. Communicate findings to Project Manager and completes a written report for distribution to the Principal Investigator and appropriate site personnel for follow-up. Assists in education of personnel in regards to research compliance when directed by the Project Manager. Assisting in the creation of corrective and preventive action plans and trending reports.
5% Other research-related duties as assignedExpected Salary:
$51,500 - $60,000Minimum Requirements:
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.Preferred Qualifications:
Master's degree in an appropriate area of specialization
Current, active Florida license as a Registered Nurse.
Oncology experience preferred.
Experience working in an academic setting is helpful.
Certification in Clinical Research Monitoring preferred.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: No
Advertised: 16 Sep 2020 Eastern Daylight Time
Applications close: 30 Sep 2020 Eastern Daylight Time