Summary
The incumbent serves as the Research Compliance Officer (RCO) at the New Mexico VA Health Care System (NMVAHCS) with responsibility to coordinate research compliance assurance activities and perform assessment and adherence to established research compliance policies and procedures at the NMVAHCS.
Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement. The Occupational Series 0671 includes an Individual Occupational Requirement (IOR). Candidates may not hold a position in this series without meeting one of the IOR requirements established by OPM. Undergraduate or graduate education in a major field of study hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. OR, Specialized experience in Missions, organizations, programs, and requirements of health care delivery systems; Regulations and standards of various regulatory and credentialing groups; and Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement. OR, Successful completion of an agency-sponsored on-the-job training program, it included a formal individualized training plan. Such a training program must have been conducted in an operating health care system and included: Assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; Practical assignments providing an opportunity to apply health system administration skills and principles (as the individual progresses, work assignments must be characteristic of the grade level to which he or she is assigned); and oversight by an experienced health system administrator with periodic evaluation of the individual's progress and appropriate adjustment of the training program. AND, In addition to meeting the IOR, you must also meet the specialized experience as described below: You may qualify based on your experience as described below: Specialized Experience GS-12: You must have one year of specialized experience equivalent to at least the next lower grade (GS-11) in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Develop policies, procedures and criteria for monitoring compliance and assisting researchers; Establishing program goals and objectives and identifies results indicative of successful program accomplishments; Prepare consolidated reports for management as part of clinical performance measures; Verifying that data from biological samples and specimens as well as all related use, handling, storage and disposition tracking data that is organized and protected during the progress of the study. and identifying problems and negotiating corrective action concerning the protection of human subjects, protection of animal, protection of personnel engaged in research. You will be rated on the following Competencies for this position: Administration and Management Communication Compliance Organizational Awareness 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; religions; 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. Note: 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. Physical Requirements: The work is sedentary. However, there is periodic walking; standing; bending; carrying of light items such as medical records, instructional materials, books and manuals. No special physical demands are required to perform the work. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at Duties "The Research Compliance Officer (RCO) ensures that research conducted meets the standards and expectations for protection of human subjects, animal welfare, research safety and laboratory security that are defined by Veterans Affairs (VA) and other Federal requirements.
In this role, the RCO: Develops, implements, maintains, and provides leadership, strategic direction, and oversight of compliance and training activities for the research program at the New Mexico VA Health Care System.
Typical duties include but are not limited to: Monitor research compliance by reviewing, auditing, and advising throughout the approval and continuing review processes.
Prepare information for research activities by gathering statistical and narrative data on project status, including resource utilization, statistical data on patient informed consent process, scientific methodology, adherence to protocols on matters such as clinical procedures, chemical use and storage, investigational drug use, dispensing and storage, security of data, and other similar matters.
Assist in the determination of the need for additional ad hoc review/representation from scientific and medical practice specialties.
Verifying implementation, control and reporting on clinical encounters.
Assess appropriateness of patients enrolled in research projects based on several factors; such as eligibility according to study protocol, execution of informed consent, and compliance with research guidelines and regulations.
Evaluate scientific and statistical data to verify compliance with regulations pertaining to human studies, through published reporting and regulatory requirements Conducts ongoing human research protection, animal welfare and research safety regulatory audits to determine compliance with all applicable policies, including ongoing research informed consent audits Coordinates auditing activities and tracking of protocol approvals by all oversight committees/ subcommittees for the purpose evaluation of required audit criteria Serves as a local resource for regulations , policies , memoranda , alerts , and other VA and federal requirements related to research compliance.
Experience in a research setting, demonstrated skill in applying research regulatory knowledge/ experience in the verification of research projects/ clinical research studies.
This position acts as the subject matter expert in providing guidance to the facility Research Service and researchers in regulatory compliance across multiple areas and requires an understanding of research conduct and regulation Work Schedule: Monday - Friday, 8:00 AM - 4:30 PM Compressed/Flexible: Supervisor's discretion 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.
Virtual: This is not a virtual position.
Position Description/PD : Health System Specialist (Research Compliance Officer)/PD12957A Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required"