Develop, coordinate and supervise research and administrative activities of clinical research studies conducted by principal investigator(s) at NSU; perform a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research studies and related data. Coordinate and oversee clinical operations of research projects including contract review, budget development and negotiation, and regulatory documents. Participate in assessing, planning, implementing and evaluating subject care in clinical research studies.
Essential Job Functions:
1. Follow the applicable regulations and institutional policies and procedures for human subjects' protections; coordinate the regulatory component of clinical trials at the NSU in collaboration with the Principal Investigator and his staff. This position includes working as a liaison with the Principal Investigator (PI), Institutional Review Board and Sponsor. 2. Assist PI to develop written informed consent forms and necessary approval forms for new protocols in accordance with OHRP regulations. Educate prospective principal investigators about the informed consent procedures, including HIPAA authorizations. Assist PIs with evaluation and development of the subject recruitment and education materials. 3. Develop clinical study budgets and payment terms with principal investigator. 4. Establish accounts for clinical research studies with college finance representative and central finance office. 5. Participate in pre-study planning and organization of the study. 6. Review clinical trial agreements prior to legal review and execution to insure clinical trial agreement language for subject injury, costs and payments is consistent with informed consent documents. 7. Coordinates the logistical aspects of clinical trials according to Good Clinical Practice and serve as pivotal point for principal investigator. 8. Coordinate research activities between the associated departments. 9. Coordinate collaborative research activities between colleges at the university. 10. Act as principal investigator's representative as appropriate. This may include communicating with governmental, private or pharmaceutical company's personnel on behalf of principal investigator. 11. Coordinate research activities, including scheduling laboratory tests, radiology testing, and/or exams for study subjects. 12. Coordinate multi-site clinical trials through the central office when NSU is coordinating site. 13. Confer with principal investigator(s) to assist to educate potential investigator and ancillary staff involved in care of subjects on aspects of the Good Clinical Practice and federal regulations related to human research protection. 14. May assist investigators with data collection, review of literature, methodology, and writing of abstracts. Investigate literature for general and specific references of interest to the research protocols and conduct library research as needed. 15. 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. 16. Use computer applications to enhance the efficiency of the workflow and study activities. 17. Participate in local research events such as workshops, support groups and community health fairs. 18. Attend research meetings and conferences as required.
Marginal Job Functions:
Required Knowledge, Skills and Abilities:
1. Ability to manage a variety of projects simultaneously. 2. Service oriented approach, flexible and proactive towards changing clients' needs. 3. Excellent verbal and written communication skills. 4. Ability to work unsupervised taking responsibility for own actions. 5. Systematically perform activities and in a timely and accurate manner. 6. Work precisely according to procedures, rules and regulations. 7. Flexible and open to change. 8. Knowledge of GCP Records.
Preferred research certification by SoCRA or ACRP
Major (if required):
Health Science, Public Health, Registered Nurse (RN) or Physician Assistant (PA)
Two (2) years of research experience.
Graduation from an accredited degree program in a Health science, Public health, Registered Nurse (RN) or Physician Assistant (PA) plus two years of research experience, or one of the following equivalents: 1. Completion of an Allied Health Degree (e.g., Respiratory Therapy, Radiologic Technology, and Licensed Practical Nurse) or Associate's Degree in Clinical Trials Research related curriculum plus a minimum of three years research experience. 2. Completion of a Bachelor's Degree in a field related to Health Science and a minimum of two years research experience. 3. Previous experience in the field of clinical research coordination and administration for a minimum of three years.
Is this a safety sensitive position (are applicants potentially subject to drug testing)?
Does this position require a criminal background screening?
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