Health Science Specialist - Research Study Coordinator

Summary

This position is located in the VA Research Program at the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), VA Medical Center, in Ann Arbor, MI. The primary purpose of this position is to perform a variety of functions, including managing clinical tests, collecting data, and recruiting and managing subjects for clinical trials while providing high-level technical support of projects in a comprehensive research setting.

Duties

THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION 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. 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. 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; Full - Time, 8:00am - 4:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Requirements

You must be a U.S. Citizen to apply for this job To be considered for this position, you must complete all required steps in the process. In addition to the application and questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job. Selective Service Registration is required for males born after 12/31/1959 Physical Requirements: 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. Subject to background/security investigation Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) - See "Required Documents" below for details. As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications

To apply for this position, you must meet the Basic Educational Requirement for this position. Individual Occupational Requirements: 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 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. AND In addition to meeting one of the Basic Requirements described above, to qualify for this position at the GS-9 level, you must meet one of the following: GS-9 EXPERIENCE: At least 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 the following: clinical tests and collecting data; recruiting human subjects for clinical trials; and 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 GS-9 EDUCATION: Requires 2 years of progressively higher-level graduate education leading to a master's 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. (Transcripts must be submitted at time of application) OR GS-9 COMBINATION: Equivalent combinations 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.(Transcripts must be submitted at time of application) In addition to meeting one of the Basic Requirements described above, to qualify for this position at the GS-11 level, you must meet one of the following: GS-11 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 (Resume(s) must clearly demonstrate the required experience to be creditable). OR GS-11 EDUCATION: Successfully completed three (3) years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree at an accredited college or university in courses related to the field of accounting. NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. OR GS-11 COMBINATION: Equivalent combinations of successfully completed graduate level education (beyond 2 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. (Transcripts must be submitted at time of application) 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. How You Will Be Evaluated

Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics): Attention to Detail Customer Service Flexibility Integrity/Honesty Interpersonal Skills Learning Reading Comprehension Self-Management Stress Tolerance Teamwork The assessment includes a cut score based on the minimum level of required proficiency in these critical general competencies. You must meet or exceed the cut score to be considered. You will not be considered for the position if you score below the cut score or fail to complete the assessment. Your 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. 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. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on the online assessment may also result in your removal from consideration. Candidates who apply under "All U.S. Citizens" announcements will be rated and ranked using Category Rating procedures. Qualified candidates will be assigned to a quality category. The categories are defined as follows: Best qualified - Applicants possessing the type and quality of experience that substantially exceeds the minimum qualifications Very Highly Qualified - Applicants possessing the type and quality of experience that exceeds, to a very considerable extent, the minimum qualifications Highly Qualified - Applicants possessing the type and quality of experience that exceeds, to a considerable extent, the minimum qualifications Well qualified - Applicants possessing the type and quality of experience that marginally exceeds the minimum qualifications of the position and who demonstrate average proficiency in most of the critical competencies Qualified - Applicants possessing the type and quality of experience that meets the minimum qualifications Application of Veterans' Preference: Category rating and selection procedures place those with veteran's preference above non-preference eligibles within each category. Preference eligible applicants that meet the eligibility and qualification requirements and who have a compensable service-connected disability of at least 10 percent are listed in the highest quality category (except when the position being filled is scientific or professional at the GS-09 grade level or higher). Other Information

Reasonable Accommodation (RA) Requests: If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments. 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. This job opportunity announcement may be used to fill additional vacancies. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's 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. 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 80 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/.