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. 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 position is located in Ann Arbor, Michigan. Responsibilities 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. This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. 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 subjects 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 Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved 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 and is at the discretion of the supervisor. NOTE: This is a TERM appointment (not-to-exceed 3 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. 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 All applicants must meet the Basic Education requirement. Basic Education Requirement: Bachelors 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 this position. This degree must be from an education program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. To qualify at the GS-09 level, in addition to meeting the Basic Education requirement, applicants must meet one of the following: SPECIALIZE EXPERIENCE: Requires one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-07) in federal service, that is directly related to the work of the position and has equipped you with the particular knowledge, skills, and abilities to successfully perform the duties as a Health Science Specialist – Research Study Coordinator. Qualifying experience includes assisting with clinical tests and collecting data; recruiting human subjects for clinical trials; utilizing a variety of software to organize and track data; maintaining research files; and providing day-to-day support for a research program. (Resume(s) must clearly demonstrate the required experience to be creditable.) -OR- SUBSTITUTION OF EDUCATION FOR EXPERIENCE (TRANSCRIPT REQUIRED): Requires 2 years of progressively higher-level graduate education leading to a masters or equivalent graduate degree with a major study in an academic field related to the medical field, health sciences, or allied sciences that is appropriate to the work of this position. -OR- COMBINATION OF EDUCATION AND EXPERIENCE (TRANSCRIPT REQUIRED): Requires an equivalent combination of successfully completed graduate level education (beyond 1 year of progressively higher-level graduate education) and specialized experience as described above, to meet the 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. To qualify at the GS-11 level, in addition to meeting the Basic Education requirement, applicants must meet one of the following: SPECIALIZED EXPERIENCE: Requires one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-9) in the Federal Service, that is directly related to the work of the position and has equipped you with the particular knowledge, skills and abilities to successfully perform the duties as a Health Science Specialist – Research Study Coordinator. Qualifying specialized experience includes coordinating clinical tests and collecting data; recruiting and managing human subjects for clinical trials; utilizing a variety of software to organize, analyze and track data; maintaining study and regulatory files; preparing reports; and providing day-to-day support for a research program. (Resume(s) must clearly demonstrate the required experience to be creditable). -OR- SUBSTITUTION OF EDUCATION FOR EXPERIENCE (TRANSCRIPT REQUIRED): A successfully completed masters or equivalent graduate degree, with a major study in an academic field related to the medical field, health sciences, or allied sciences that is appropriate to the work of this position. -OR- COMBINATION OF EDUCATION AND EXPERIENCE (TRANSCRIPT REQUIRED): Requires an equivalent combination of successfully completed graduate level education (beyond 1 year of progressively higher-level graduate education) and specialized experience as described above, to meet the 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. 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: The work is primarily sedentary with occasional walking, standing, and handling, and carrying items such as paper and books. There may be occasional needs to assist study participants with mobility to study locations(s). Some travel will be required. For more information on these qualification standards, please visit the United States Office of Personnel Managements 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: Recognition of Foreign Qualifications | International Affairs Office (ed.gov). Additional Information This job opportunity announcement may be used to fill additional vacancies. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. 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. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicants criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act.