Health Science Specialist - Research Study Coordinator

Summary
This position serves as Health Science Specialist - Research Study Coordinator within the Research and Development (R&D) Service located in Dayton, OH. The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden.
This job is open to

• The public
  U.S. Citizens, Nationals or those who owe allegiance to the U.S.

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Duties
***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION***
The Research Study Coordinator manages clinical tests, collects data, and recruits and manages subjects for clinical trials while providing high-level technical support of projects in a comprehensive research setting. Duties and responsibilities include but are not limited to:
Manages Clinical Tests and Collects Data

• Collects and analyzes data, educates, and interacts with study participants and leadership
• Provides detailed and summary information and recommendations for further actions based on the data analysis

• Manages implementation, control and reporting on clinical tests
• Implements data collection and monitors protocols for difficult clinical research studies
• Administers or monitors administration of tests and measurements required by project design
• Records data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study
• Identifies test results and trends requiring further analysis
• Maintains all study and regulatory records
• Prepares project and statistical reports for review process

Recruits and Manages Candidates for Clinical Trials

• Oversees, screens, and evaluates recruitment of candidates for clinical research studies via telephone and/or in person
• Uses objective rating techniques to identify potential candidates for participation in study where project design is complex
• Performs informed consent process throughout the study and continuously educates participants on study processes and procedures
• Performs day-to-day activities related to conducting and overseeing participant interviews and follow-up
• Coordinates study participant randomization to treatment, works closely with the Research Pharmacy on study drug provision

Research Project Support

• Assists supervisor with managing the routine, day-to-day activities, and administration of the project
• Plans, develops, completes, and submits on time all required documentation/ paperwork/forms for initial and continuing human subject's review
• Analyzes processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations
• Conducts quality assurance evaluations for project data and clinical research instruments, as applicable. Establishes and monitors remediation plans to correct deficiencies
• Drafts detailed and summary reports for presentation at meetings and conferences and for publication in peer reviewed journals
• Compiles and produces educational and training materials; determines contents needed for training binders and tools

Work Schedule: Monday-Friday, 8:00am - 4:30pm
NOTE: This is a TERM appointment (not-to-exceed 4 years). Term appointments are non-status, nonpermanent appointments of limited duration (more than 1 year but not more than 4). Term employees are eligible to earn leave and generally have the same benefits as permanent employees including health and life insurance, within-grade increases and Federal Employees Retirement System and Thrift Savings Plan coverage. Term appointments may be extended without further competition (up to the 4 year maximum). The appointment to a Term position does not confer eligibility for promotion or reassignment to other positions or the ability to be non-competitively converted to permanent employment.
Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
Recruitment & Relocation Incentives: Not authorized
Financial Disclosure Report: Not Required
Requirements
Conditions of Employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• You may be required to serve a probationary period
• Subject to background/security investigation
• Selected applicants will be required to complete an online onboarding process
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
• Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.

Qualifications
Basic Education Requirement: 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. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. A transcript is required at the time of application.
To qualify at the GS-11 level you must one of the following minimum qualification requirements in addition to the basic education requirement above.
Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Research Study Coordinator and provided you with knowledge of the full scope of activities required in conducting single and/or multi-site clinical research including study/project management, human subjects' protection, and regulatory and policy compliance. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-9) in the normal line of progression for the occupation in the organization. Specialized experience includes:

• Performing a variety of tasks related to the conducting of the clinical/healthcare related research such as participant recruitment and enrollment, protocol execution, data reporting and management, and regulatory compliance
• Screening and evaluating the recruitment of candidates for clinical research studies
• Analyzing processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations
• Utilizing software used for project management, data collection, and regulatory compliance to extract, organize, track, and analyze data, produce letters and memorandums, and prepare a variety of documents and presentations
• Conducting telephone and in-person interviews of human study subjects using various methods of data collection

- OR -
Education: You may substitute the specialized experience with education if you possess a Master's or equivalent graduate degree that provided the knowledge, skills, and abilities necessary to do the work. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work of this. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation.
- OR -
Combination: A combination of successfully completed graduate level education (beyond two years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree) and specialized experience may also be used to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation.
You will be rated on the following Competencies as part of the assessment questionnaire for this position:

• Communications
• Critical Thinking
• Manages and Organizes Information
• Project Management
• Research

IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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.
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; religious; 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.
Physical Requirements and Work Environment: The work is primarily sedentary with occasional walking, standing, and handling and carrying items such as paper and books. There may be occasion needs to assist study participants with mobility to study location(s). Some travel will be required. The work is performed in a research setting requiring no special considerations beyond accepted standards of safety. The work area is adequately lighted, heated, and ventilated. There may be occasional exposure to moderate risks or during program/project and country visits.
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/.
Education
IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.
NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.
Additional information
Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities (i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities), and/or disabled veterans with a compensable service-connected disability of 30% or more. For more information on how to apply using this appointment authority via the Selective Placement Coordinator within the office, contact the facility Human Resources Department at (937) 268-6511.
The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 85 or more before any Veterans preference points) for this vacancy. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/.
This job opportunity announcement may be used to fill additional vacancies.
If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement.

• Benefits
  A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
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  Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
Your responses to the assessment questionnaire will be reviewed along with the information p...