Summary This position serves as a Health Science Specialist - Research Study Coordinator, and is located within the Research and Development (R&D) Service at the VA Medical Center in Nashville, TN. The position is fully responsible to manage clinical tests and collect data, recruit, and manage subjects for clinical trials and provide high level technical support of projects in a comprehensive research setting, providing day-to-day support for the VA Research Program. Responsibilities 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 four years). Term appointments are non-status, nonpermanent appointments of limited duration. 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. Duties may include, but are not limited to the following: 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 Performs other related duties as assigned. Work Schedule: Monday - Friday, 7:00am - 3:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved 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 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 dentification 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) 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 period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications To qualify for this position, you must meet the following requirements: BASIC REQUIREMENT: Bachelor's degree (or higher) from an accredited college or university in a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of a Health Science Specialist - Research Study Coordinator. (Copies of transcripts are required at the time of application) In addition to meeting the basic requirement above, you must also meet one of the following requirements. SPECIALIZED EXPERIENCE: 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: 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; and Conducting telephone and in-person interviews of human study subjects using various methods of data collection. -OR- EDUCATION: Master's or equivalent graduate degree, in a related field of the position to be filled. Education at the graduate level must have been obtained in an accredited college or university and must demonstrate the knowledge, skills, and abilities necessary to do the work of this position. NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. -OR- COMBINATION: Equivalent combination of successfully completed graduate level education (beyond 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree) 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. This education must have been obtained in an accredited college or university. NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. Experience must be clearly indicated in your resume. 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 occasion needs to assist study participants with mobility to study location(s). Some travel will be required. 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: Recognition of Foreign Qualifications | International Affairs Office (ed.gov). Additional Information Note: Per "Executive Order 14251: Exclusions from Federal Labor-Management Relations Programs", this position is no longer eligible for bargaining unit participation. 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. 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.
