Health Science Specialist

Responsibilities

• Coordinating all work-related activities required to complete single-site or multi-site projects
• Managing regulatory documents and submitting to the Institutional Review Board (IRB) and the Research and Development (R&D) Committee all documents required for project approval
• Providing or monitoring of projects and adheres to all applicable deadlines for submission of regulatory reports including adverse event reports, annual reports and other reports
• Assisting with data collection, document retrieval, and writing reports needed to obtain initial and ongoing approval of the protocol by the IRB and R&D Committees
• Assisting with developing and maintaining a Standard Operating Procedures (SOP) manual and adhering to this manual when administering and implementing the project protocol
• Completing all aspects of the screening and recruitment process as stipulated in the project protocol and ensures that all patients/subjects included in the project meet all inclusion and no exclusion criteria
• Keeping patients/subjects or their legal representative informed about all aspects of the project in which they are participating
• Utilizing and maintaining an electronic record management system for each project and using it to record all applicable recruitment, procedure, and interview data
• Managing participant compensation and maintaining compensation records; preparing invoices for reimbursement of participants
• Completing assigned components of the initial (baseline) and follow-up/interim subject/patient assessment
• Preparing and reviewing status reports and statistical data to verify compliance with reports and administrative criteria
• Abstracting medical records to obtain data for each project as stipulated in the protocols
• Providing data summaries and other project information that is required to complete all mandated project reports
• Promoting building of team cohesiveness and effective communication with all individuals involved in any aspect of the project to enable effective team functioning and successful completion of the project
• Training other Health Science Specialists and verifies that they understand and adhere to all aspects of the protocol and all relevant policies, can reliably and correctly perform all procedures
• Performing the duties of a Level 1 quality assurance reviewer which entails auditing research study records for the presence of documentation required to maintain compliance with R&D and IRB standards/requirements
• Monitoring and evaluating quality of all data and using proper approach for correcting all errors identified
• Creating daily data monitoring reports to present on-going status of data to the project lead
• Participating in establishing operational guidelines for the use of each project assessment instrument
• Utilizing appropriate software, entering all data into designated electronic databases and accurately transcribes recorded patient/subject interviews
• Conducting ongoing intra- and inter-rater reliability testing of all project instruments
• Utilizing various library and on-line search engines to perform extensive literature searches on specific topics as required for a given research or clinical project
• Preparing bibliographies for use in various educational materials and tools, journal article submissions, and grant applications
• Compiling and producing education and training materials
• Assisting in the preparation of manuscripts authored by a project lead for publication in peer-reviewed health/medical journals
• Conducting research for the papers and abstracting relevant literature
• Other related duties as assigned

Benefits

• This position may be authorized for telework.
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Qualifications

• Bachelor's or graduate/higher level degree - major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position
• You must have one (1) year of specialized experience that equipped you with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (i.e., GS-07) in the normal line of progression for the occupation in the organization
• Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 2 years of progressively higher-level graduate education leading to a master's degree or master's or equivalent graduate degree. This education must have provided the knowledge, skills, and abilities necessary to do the work (i.e., major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position)
• Applicants may also combine education and experience to qualify at this level. You must have a combination of specialized experience and education. Only graduate-level education in excess of the amount required for the next lower grade level (1 year of graduate-level education, i.e., 18 semester hours) may be combined with experience. For example, an applicant with 6 months of appropriate experience equivalent to GS-7 (50 percent of the experience requirement for GS-9) and 27 semester hours of appropriate graduate education (50 percent of the education requirement for GS-9, in excess of that required for GS-7) would be qualified for a GS-9 position (assuming that there is no evidence that the attended college or university requires more than 18 semester hours as equivalent to a year of graduate study)
• You must have one (1) year of specialized experience that equipped you with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (i.e., GS-07) in the normal line of progression for the occupation in the organization.
• Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 2 years of progressively higher-level graduate education leading to a master's degree or master's or equivalent graduate degree. This education must have provided the knowledge, skills, and abilities necessary to do the work (i.e., major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position).

Required skills

• Advance Care Planning, Clinical Research, Data Analysis, End-of-Life Care, Human Subjects Research, Institutional Review Board (IRB) Processes, Manuscript Editing, Medical Record Abstraction, Research Project Coordination, Research Regulatory Compliance, Statistical Analysis, Subject Interviewing

Experience

• 1+ years