Health Science Specialist
Specific duties require knowledge of the full scope of activities required to conduct clinical research including study/project management, human subject's protection, and regulatory and policy compliance. The incumbent is responsible for participant recruitment/enrollment, coordination of study activities, data collection, analysis of data and project activities, documentation of activities,meeting reporting requirements, and providing oversight to study activities under the site Principal Investigator's authority. The incumbent ensures that all research activities are documented as required by the specific protocol, adhering to Federal and VA guidelines/requirements. The Health Science Specialist aids in constructing research reports which may include collecting and analyzing study data; regular written and/or oral communications to the Principal investigator describing their personal tasks, responsibilities, and results will be required. The Health Science Specialist may be asked to provide technical advice to the Pl, such as:
technical advice on submission requirements for the IRB or on equipment and supplies used in the study. Support, facilitate, and coordinate clinical research studies in accordance with the study protocol which will vary based on the grant funding approved. Assist with document preparation by collecting required data or completing required forms and submission to, including, but not limited to, VA Central IRB, Office of Research and Development, Local IRB, Local R&D, and Local Research Compliance Office (RCO) for obtaining necessary regulatory oversight and approvals. Obtain verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information (as needed) from patients ensuring that the process adheres to HIPAA, information security and other federal regulations regarding confidentiality and the conduct of human subjects' research. Help obtain and/or analyze Informed Consent forms to ensure that they are complete, accurate, current, and contain the appropriate signatures. Identify issues, such as a deviation from the protocol, and work with local site Pl and national work groups to resolve such issues. Recruit, screen, and interview human research participants to collect health information via telephone and/or in person, conducting follow up procedures as necessary. Conduct structured clinical interviews and health assessments with study participants as needed. Perform routine clinical tests, as required by protocol, including drawing blood, monitoring vital signs, and measuring various organ, and physical functions, if relevant to the study protocol. Extract, review, and organize data from research subjects' medical records. Recruit human research subjects, based on eligibility criteria from Computerized Patient Record System (CPRS) or other database sources, perform medical record abstraction, and maintain tracking databases to chart study progress. Manage electronic project tracking system, recording recruitment and interview information and regularly updating the system. Facilitate and monitor the transcription process of interviews, as applicable. Help with audits of research study records for compliance with sponsor, Research and Development and Institutional Review Board (IRB) standards/requirements by coordinating audit site visits, gather/copy data and records to be reviewed, and answer questions about the study. Participate and be engaged with national meetings (including teleconferences) related to conducting the study, with colleagues at VACO, VA ORD, VA research infrastructure and other stakeholders. Conduct studies in accordance to Good Clinical Practice and related clinical research standards for quality. Lead the management of the routine, day-to-day activities and administration of the project. Plan, develop, complete, and submit on time all required documentation/paperwork/forms for initial and continuing human subject review through anational research software program. Analyze study processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations. Regularly review guidance, policies, and procedures to maintain regulatory compliance. Provide technical guidance to research staff regarding regulations, policies, and procedures applicable to the conduct of research. Perform other duties as assigned. Work Schedule:
Monday thru Friday 8am- 430pm Compressed/Flexible:
Not Available Telework:
Not Available Virtual:
This is not a virtual position. Position Description/PD#:
Health Science Specialist/PD20E43-A Relocation/Recruitment Incentives:
Not Authorized Financial Disclosure Report:
Not required To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 11/20/2020. Time-In-Grade Requirement:
Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-9 position you must have served 52 weeks at the GS-7. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note:
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience and/or education as described below:
Specialized
Experience:
You must have at least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-7) in the Federal service that has given you the particular knowledge, skills and abilities required to successfully perform the duties of a Health Science Specialist, and that is typically in or related to the work of the position to be filled. Specialized experience is experience that requires application of the knowledge of research methodology and techniques used in administering questionnaires and conducting patient interviews in a research health care environment; recruiting and screening potential research participants, and accurately collecting and recording data; utilizing appropriate communication techniques for interviewing study participant, providing consultative services or program guidance; and using computer software for entering data and preparing reports. NOTE:
Experience must be fully documented on your resume and must include job title; duties; month and year start/end dates AND hours worked per week. OR, Education:
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. OR, Combination:
Equivalent combinations of successfully completed graduate level education (beyond the first year) and specialized experience, as described above, which may be used to meet total experience requirements for this grade level. The education portion must include courses that provided the knowledge, skills, and abilities necessary to do the work of the Health Science Specialist position. NOTE:
Transcripts (unofficial or official) must be submitted with your application materials. Education cannot be credited without documentation. You will be rated on the following Competencies for this position:
Manages and Organizes InformationProject ManagementQuality ManagementResearchTechnical Competence Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note:
A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements:
The person in this position will be sitting, standing, and walking to carry out required duties. No strenuous physical demands will be made. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
Estimated Salary: $20 to $28 per hour based on qualifications.
technical advice on submission requirements for the IRB or on equipment and supplies used in the study. Support, facilitate, and coordinate clinical research studies in accordance with the study protocol which will vary based on the grant funding approved. Assist with document preparation by collecting required data or completing required forms and submission to, including, but not limited to, VA Central IRB, Office of Research and Development, Local IRB, Local R&D, and Local Research Compliance Office (RCO) for obtaining necessary regulatory oversight and approvals. Obtain verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information (as needed) from patients ensuring that the process adheres to HIPAA, information security and other federal regulations regarding confidentiality and the conduct of human subjects' research. Help obtain and/or analyze Informed Consent forms to ensure that they are complete, accurate, current, and contain the appropriate signatures. Identify issues, such as a deviation from the protocol, and work with local site Pl and national work groups to resolve such issues. Recruit, screen, and interview human research participants to collect health information via telephone and/or in person, conducting follow up procedures as necessary. Conduct structured clinical interviews and health assessments with study participants as needed. Perform routine clinical tests, as required by protocol, including drawing blood, monitoring vital signs, and measuring various organ, and physical functions, if relevant to the study protocol. Extract, review, and organize data from research subjects' medical records. Recruit human research subjects, based on eligibility criteria from Computerized Patient Record System (CPRS) or other database sources, perform medical record abstraction, and maintain tracking databases to chart study progress. Manage electronic project tracking system, recording recruitment and interview information and regularly updating the system. Facilitate and monitor the transcription process of interviews, as applicable. Help with audits of research study records for compliance with sponsor, Research and Development and Institutional Review Board (IRB) standards/requirements by coordinating audit site visits, gather/copy data and records to be reviewed, and answer questions about the study. Participate and be engaged with national meetings (including teleconferences) related to conducting the study, with colleagues at VACO, VA ORD, VA research infrastructure and other stakeholders. Conduct studies in accordance to Good Clinical Practice and related clinical research standards for quality. Lead the management of the routine, day-to-day activities and administration of the project. Plan, develop, complete, and submit on time all required documentation/paperwork/forms for initial and continuing human subject review through anational research software program. Analyze study processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations. Regularly review guidance, policies, and procedures to maintain regulatory compliance. Provide technical guidance to research staff regarding regulations, policies, and procedures applicable to the conduct of research. Perform other duties as assigned. Work Schedule:
Monday thru Friday 8am- 430pm Compressed/Flexible:
Not Available Telework:
Not Available Virtual:
This is not a virtual position. Position Description/PD#:
Health Science Specialist/PD20E43-A Relocation/Recruitment Incentives:
Not Authorized Financial Disclosure Report:
Not required To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 11/20/2020. Time-In-Grade Requirement:
Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-9 position you must have served 52 weeks at the GS-7. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note:
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience and/or education as described below:
Specialized
Experience:
You must have at least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-7) in the Federal service that has given you the particular knowledge, skills and abilities required to successfully perform the duties of a Health Science Specialist, and that is typically in or related to the work of the position to be filled. Specialized experience is experience that requires application of the knowledge of research methodology and techniques used in administering questionnaires and conducting patient interviews in a research health care environment; recruiting and screening potential research participants, and accurately collecting and recording data; utilizing appropriate communication techniques for interviewing study participant, providing consultative services or program guidance; and using computer software for entering data and preparing reports. NOTE:
Experience must be fully documented on your resume and must include job title; duties; month and year start/end dates AND hours worked per week. OR, Education:
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. OR, Combination:
Equivalent combinations of successfully completed graduate level education (beyond the first year) and specialized experience, as described above, which may be used to meet total experience requirements for this grade level. The education portion must include courses that provided the knowledge, skills, and abilities necessary to do the work of the Health Science Specialist position. NOTE:
Transcripts (unofficial or official) must be submitted with your application materials. Education cannot be credited without documentation. You will be rated on the following Competencies for this position:
Manages and Organizes InformationProject ManagementQuality ManagementResearchTechnical Competence Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note:
A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements:
The person in this position will be sitting, standing, and walking to carry out required duties. No strenuous physical demands will be made. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
- Department:
0601 General Health Science - Salary Range:
$54,844 to $71,298 per year
Estimated Salary: $20 to $28 per hour based on qualifications.
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