Health Science Specialist - Research Study Coordinator

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/.

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.