[Hiring] Supervisory Health Science Specialist @Durham VA Medical Center

Role Description

This position is within the VA Health Care System National TeleOncology Program and works closely with the National Oncology Program (NOP). The Supervisory Health Science Specialist is responsible for supervising the VA Cancer Clinical Research Service, including Decentralized Clinical Trials and Cancer Trials Navigation programs.

The Supervisory Health Science Specialist serves as the Cancer Clinical Research Service Program Manager and is responsible for overseeing the conduct of decentralized clinical trials (inclusive of NCI-sponsored, VA-sponsored, and pharmaceutical-sponsored clinical trials) and cancer clinical trial navigation under the direction of the Clinical Research Oncologist. The Supervisory Health Science Specialist possesses expertise in clinical trial activation and management, program implementation and improvement, and the conduct of human subjects research and provides expert guidance and support to the Clinical Research Oncologist, research team, research staff at other VA sites, National TeleOncology Hub and Program Office leadership, and leadership within the National Oncology Program.

Duties may include, but are not limited to the following:

• Review study documents to plan and develop timelines for study-specific tasks and delegate tasks to appropriate research staff.
• Provide guidance to the regulatory coordinator in preparing and submitting documentation for initial and continuing review to appropriate institutional review boards.
• Analyze processes and documentation to ensure compliance with regulatory, privacy, and information security requirements.
• Communicate with providers at other VA facilities regarding available clinical trials and potential research subjects.
• Develop and use evaluation metrics to improve recruitment and screening procedures.
• Evaluate data collection quality and establish and monitor remediation plans to correct deficiencies.
• Provide technical guidance to other members of research team regarding the conduct of human subjects' research, including regulations, policies, and procedures.
• Respond to inquiries from research staff (locally and nationally) and other stakeholders.
• Correspond with others regarding the Decentralized Clinical Trials (DCT) program and individual clinical trials, including memoranda and reports.
• Create and update standard operating procedures for implementing and opening DCTs in VA network of facilities.
• Track required training and certifications for study personnel, and assure they are maintained and up to date.
• Explain and educate potential research subjects regarding the nature and purpose of clinical research in general and specific clinical trials for which they are eligible.
• Prepare and participate in audits and monitor visits, for compliance with the sponsors, R&D and Institutional Review Board (IRB), and National Cancer Institute (NCI) cooperative groups.
• Responsible for work assignments, determining priorities, leave approval, counseling / disciplinary actions, and training needs.
• Provide technical and administrative supervision to the unit.
• Oversee the daily operation of the unit, ensures that agency policies and priorities are being followed; develops performance standards; and evaluates work performance of subordinates.
• Gives advice, counsel, and instruction to employees on both work and administrative matters.
• Performs other related duties as assigned.

Qualifications

• Possess 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 the position.
• This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application will not be reviewed.)
• Possess at least one (1) full year of specialized experience that equipped you with the particular knowledge, skills, and abilities to perform successfully the duties of the position.
• Specialized experience must have been equivalent to at least the next lower grade level of (GS-11) in Federal service.
• Specialized experience is: experience coordinating and managing clinical research activities and clinical trials; applying requirements for regulatory compliance and protection of human research subjects; preparing and maintaining clinical research and Institutional Review Board (IRB) documentation; monitoring clinical trial activities and maintaining accurate study records and documentation; managing multiple clinical research activities with competing deadlines; and communicating clinical research requirements and information to multidisciplinary research teams and study participants.

Requirements

• Selective Placement Factor: Possess professional experience managing and coordinating oncology clinical research or oncology clinical program activities.
• 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.
• Applicants will be required to complete a Supervisory Situational Judgment Test (SSJT) as part of the assessment process for this position.
• A full year of work is considered to be 35-40 hours of work per week.
• Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations.

Benefits

• Recruitment & Relocation Incentives: Not authorized.
• Critical Skills Incentive (CSI): Not Approved.

Physical Requirements

The work is primarily sedentary, but does require walking, standing, and carrying light to moderately heavy packages or boxes (e.g., study documentation in binders, samples for shipping). Some travel will be required.