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

Gap Solutions•Bethesda, MD

About The Position

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.

Requirements

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

Nice To Haves

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

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.
Assist researchers obtain IRB approval before any study related activities begin.
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.
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).
Develop and maintain research protocol documentation and operations.
Assist researchers with study testing, observations data entry and other duties associated with study sessions.
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