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***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.

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

• 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

• 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

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

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 OF EXPERIENCE AND EDUCATION: 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

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 provided in your resume and supporting documentation to determine if you are qualified for the position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your rating may be lowered and/or you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.

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 experience that substantially exceeds the minimum qualifications of the position including all selective factors, and who are highly proficient in all requirements of the job and can perform effectively in the position;
• Highly qualified - applicants possessing experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the requirements of the job;
• Well qualified - applicants possessing experience that meets the minimum qualifications of the position including all selective factors, and who are proficient in some, but not all, of the requirements of the job; and
• Qualified - applicants possessing experience and/or education that meets the minimum qualifications of the position including all selective factors.