Clinical Research Coordinator Audiologist (Part-Time) (52666)

Job DetailsLevel: ExperiencedJob Location: National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD 20892Position Type: Part TimeEducation Level: Ph.D.Salary Range: $68.00 - $78.00 HourlyTravel Percentage: NoneJob Shift: DayJob Category: Public HealthPosition Objective: The Clinical Research Coordinator Audiologist provides advanced clinical and scientific support to the HearGene Connect study for the National Institute on Deafness and Other Communication Disorders (NIDCD), Division of Intramural Research within the National Institutes of Health. This part-time position supports a national study on inherited hearing loss through community outreach and participant enrollment, preparation of ethics review documentation, oversight of hearing test data quality, and collaboration on research analysis and scientific publication. Duties and Responsibilities: . Assist preparing and submitting for review accurate source documents related to all research procedures. Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). Participate in developing and maintaining research protocol documentation and operations. Assist researchers with study testing, observations data entry and other duties associated with study sessions. Verify study participant information and collect data and results of testing. Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols. Perform accurate and timely data analysis, report results and findings and respond to sponsor queries. Enter data into research databases, systems and applications for ongoing studies. Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates. Review draft protocols, case report forms, and manuals of operations for clarity, and completeness. Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries. Assist researchers with the collection and analysis of research data and samples. Assist staff writing progress reports and contributions to peer-reviewed scientific manuscripts. 4 Assist researchers obtain IRB approval before any study related activities begin. 5 Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures. Assist researchers develop and maintain current and new research protocols. 1 Maintain content on the Clinical Studies websites (resources for staff and extramural investigators). Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system. Work with investigators to maintain Protocol Applications within the protocol management database system. Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System. Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. Prepare and submit for review accurate source documents related to all research procedures. Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). 2 Develop and maintain research protocol documentation and operations. Assist researchers with study testing, observations data entry and other duties associated with study sessions. 3 Organize, prepare and distribute informational materials and provide support to the educational mission of the study. Meet with lab members to present updates Technical Reports and Scientific Communications Regulatory and Compliance Documentation Manuscripts and Presentations Outreach Plan and Materials QualificationsBasic Qualifications: Doctoral degree in audiology or related discipline State license to perform audiology testing Skilled in Manuscript/publication tools, Statistical analysis software (e.g., SPSS/R/SAS), and mage/data extraction and management software Skilled in Statistical/data analysis software, Image analysis/data extraction Software, and Clinical Trial Management System (CTMS) Experience in audiology and/or clinical trials and ability to maintain accurate and detailed laboratory records Experience identifying, evaluating and establishing clinical trial sites and Implementation of clinical trial site action plans Preferred Qualifications: Ability to communicate effectively, orally and in writing, with non-technical and technical staff Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law. This position is contingent upon contract award.