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Clinical Research Coordinator II - 994034
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Job Number: 503940
Work Type: Full Time with Full Benefits
Location: Fort Lauderdale-Davie, Florida
Department: Office for Clinical Research
Categories: Research, Service, & Sponsored Programs
| About Us: |
We are excited that you are considering joining Nova Southeastern University!
We appreciate your support in making NSU the preeminent place to live, work, study and grow. Thank you for your interest in a career with Nova Southeastern University. NSU considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status or any other legally protected status. |
| Job Title: | Clinical Research Coordinator II - 994034 |
| Location: | Fort Lauderdale-Davie, Florida |
| Work Type: | Full Time with Full Benefits |
| Job Category: | Non-Exempt |
| Hiring Range: | $43,000-48,000 |
| Pay Basis: |
Hourly |
| Subject to Grant Funding?: | No |
| Essential Job Functions: | 1. Conduct the clinical study accurately and in compliance with FDA regulations and GCP guidelines to ensure the safety and welfare of the study participants. 2. Assist in the development of guidelines for the collection of clinical data and/or administration of clinical studies. Design and maintain organizational tools. Coordinate the development of forms, questionnaires and the application of research techniques; assist in writing procedures manuals for data collection and coding. 3. Participate in pre-study planning and organization of the study start up tools. Design a recruitment plan for each clinical trial. 4. Develop written Informed Consents for new protocols in accordance with FDA regulations. Prepare IRB applications and forms, safety reports, amendments and renewals. 5. Prepare and mainain regulatory documents to include FDA forms, Safety reports, and IRB correspondence. 6. To learn new EMR system and utilize for clinical study recruitment and recording activities. 7. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; collect data and maintain appropriate documentation in the case report forms in accordance with the protocol so that all study activities are documented correctly and completely; obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Centrifuge, process, store and ship samples. 8. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events. 9. Report all adverse events and unanticipated problems to the investigator and reserch director, study sponsor and IRB. 10. Present all collected clinical data to the principal investigator(s) as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Confer with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication. 11. Recruit and screen the potential study participants according to the protocol's inclusion and exclusion criteria, schedule study participant's visits and during the study participant's visit perform defined activities of the study completely and accurately. Obtain proper written informed consent from each study participant prior to participation in the study. Maintain adequate and accurate case histories for each study participant that records all observations and data during the study. 12. Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate. 13. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. 14. Use computer applications to enhance the efficiency of the work flow and study activities. 15. Written, verbal and interpersonal communication with study sponsor as required. 16. Participate in local research events such as workshops, support groups and community health fairs. 17. Assist Manager in budget preparation associated with protocols. |
| Marginal Job Functions: | |
| Required Knowledge, Skills, & Abilities: | 1. Ability to function independently and manage a variety of projects simultaneously. 2. Attentiveness to detail. 3. Multi-tasking capability. 4. Good interpersonal, verbal and sritten communication skills. 5. Ability to meet a flexible work schedule. 6. Knowledge of GCP. 7. Ability to use electronic data systems. |
| Job Requirements: | |
| Required Certifications/Licensures: | |
| Required Education: | High School Diploma or Equivalent |
| Major (if required): | |
| Required Experience: | High School diploma or equivalent and four (4) or more years of related relevant experience. --OR-- Associate’s degree/60 credit hours and two (2) years’ relevant experience. |
| Preferred Qualifications: | Experience in the field of clinical research |
| Is this a safety sensitive position? | No |
| Background Screening Required? | No |
| Pre-Employment Conditions: |
To ensure a safe learning environment for students and staff, as a condition of employment the selected candidate will need to provide proof of a completed COVID-19 vaccination prior to commencement of employment or an approved exemption and reasonable accommodation.
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| Sensitivity Disclaimer: | Nova Southeastern University is in full compliance with the Americans with Disabilities Act (ADA) and does not discriminate with regard to applicants or employees with disabilities, and will make reasonable accommodation when necessary. |
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