DENTAL STUDY EXAMINER ORAL MEDICINE
Duties: The Dental Examiner for the Department of Oral Medicine is responsible for the supporting the Oral Diagnosis Clinic and leading the study and examination process and programs for the department which includes independent coordination, study recruitment and secure the enrollment of patients in various study efforts.
The Dental Examiner provides professional level support for research studies and assists in the design of studies. Develops, verifies and implements procedures to accomplish research goals. Implements research protocol and monitors participant adherence to protocol. Assumes responsibility for coordinating study participant recruitment, enrollment, and informed consent process. Performs study assessments, interviews, and specimen collections and ensures proper collection and handling of specimens according to study protocol and established procedures. Submits data reports as requested by the Principal Investigator in a timely, efficient manner with supporting documentation. Provides complete and timely follow-up in reporting pertinent clinical findings and laboratory results. Verifies accuracy of research data and monitors data quality control. Prepares and submits annual reviews to the Institutional Review Board (IRB). Maintains consent forms and sponsor correspondences. Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations. Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records in compliance with IRB protocol. Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants. Determines data to be collected and develops forms for collecting/summarizing data. Maintains and assists with clinical research computer database(s) and enters data onto case reports and/or into database as appropriate. Ensures data integrity and consistency in computer database and written records. Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed. Establishes/maintains contact with patients/participants, health care providers, community agencies and study sponsors. Updates appropriate agencies (such as sponsors, IRB, etc) regarding current status of research project. Provides in-service education to staff and patients/participants about research protocols. Performs other duties as assigned.
The Examiner will collaborate with PI's to develop and implement recruitment strategies in accordance with IRB requirements, links patients to research studies utilizing and ensure study-related visits/procedures are linked to studies according to University policies and guidelines, screen potential subjects for eligibility using protocol specific inclusion and exclusion criteria and document each potential participant's eligibility, conduct informed consent process for patients and obtain appropriate signatures and dates, interact with the IRB members and research participants to answer any questions related to assigned studies, collaborate with research departments (regulatory, QA) and sponsors to respond to any monitoring/audit findings and help facilitate approved recommendations, attend investigator meetings, review assigned protocols, study operations and timelines, inclusion and exclusion criteria, confidentiality to gain familiarity with studies
Qualifications: Bachelor's degree in medical sciences or related discipline required. 3-5 years of relevant work experience in clinical research or clinical trials management. Computer skills related to data management required. Data analysis skills and basic understanding of statistics. Ability to work independently and collaborate with a team. Flexibility and willingness to work evenings or weekends if necessary. Any appropriate combination of relevant education, experience and/or certifications may be considered.
Reference Number: 51-28743
Salary Grade: 026
Employment Type: Exempt
Org: Oral Medicine
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: A-General/Professional Administrative