Research Quality Assurance Specialist

Houston VA Research and Education; Houston (TX); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Houston VA Research & Education Foundation (HVAREF) seeks a Quality Assurance Specialist to support the Office of Quality Assurance for Research at MEDVAMC. You will assist with SOPs, regulatory oversight, and documentation for accreditation, audits, and IRB processes.

The role requires 3+ years of clinical science research experience, strong communication, attention to detail, and data analysis skills. A hybrid work arrangement is available after probation, with an 8-hour Monday–Friday schedule

Qualifications

• Requires a Bachelor’s degree or higher in a scientific discipline, health care administration, business admin, or four years of relevant work experience in health care or academic setting.
• Master’s degree is preferred.
• Must have no less than 3 years of clinical science research experience.

Responsibilities

• Assist in updating policies and SOPs.
• Identify and resolve process issues; support continuous quality improvement.
• Support compliance and quality assurance and external regulatory site visits.
• Organize and compile documents for accreditation, audits, site visits, submissions and responses.
• Serve on quality improvement/accreditation teams as requested.
• Review Conflict of Interest disclosures and training documentation.
• Provide guidance on deficiencies in protocol submissions and recommendations for modifications.
• Ensure accuracy of submitted materials and assist investigators with ISVAR/VAIRRS.
• Provide customer service and education to Principal Investigators and study staff for protocols submitted to the IRB/SRS/RDC.
• Track IRB continuing reviews, amendments, and other regulatory milestones.
• Assist with regulatory oversight of various IRBs.
• Input and maintain research databases (ISVAR and VAIRRS).
• Perform other duties as assigned.

Skills

Excellent oral and written comms

Strong attention to detail

Strong data collection and analysis

Computer proficiency

Education

Bachelor’s degree or higher in a scientific discipline

Master’s degree (preferred)

Job description

Houston VA Research & Education Foundation (HVAREF)

Introduction

The Research Service Line at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) is seeking a Quality Assurance Specialist. This position is funded through the Houston VA Research & Education Foundation (HVAREF). This position is responsible for providing support to the Office of Quality Assurance for Research for studies conducted at the Michael E. DeBakey VA Medical Center (MEDVAMC) in support of VA research.

Duties:

• Assists in updating policies and standard operating procedures.
• Assists in identifying and resolving process issues as well as making recommendations for continuous quality improvement.
• Assists with compliance and quality assurance issues and supports external regulatory site visits, providing regulatory input to minimize potential for non‑compliance findings.
• Assists with organizing and compiling support documents and information for accreditation, audit, and site visit reports, submissions, and responses under leadership guidance.
• Serves on quality improvement/accreditation teams as requested.
• Collects and reviews Conflict of Interest Disclosures and training documentation.
• Assists in providing written or verbal instructions on deficiencies of protocol submissions and makes recommendations regarding modifications required to address deficiencies.
• Ensures accuracy of submitted materials. Works with investigators and staff, to resolve technical problems associated with research submissions.
• Provides customer service and education to Principal Investigators, Co‑Investigators, and Coordinators for protocols submitted to the Research and Development Committee (R&DC), Subcommittee for Research Safety (SRS) and Institutional Review Board (IRB).
• Assists with initial review of quality improvement project determination.
• Assists with tracking IRB Continuing Reviews, amendments, 5‑year projects, lapses, etc.
• Assists with regulatory oversight of various IRBs.
• Assists with Inputting and maintaining up‑to‑date Research databases (Informatics System for VA Research (ISVAR) and VA Innovation and Research Review System (VAIRRS) for research protocols.
• Performs other job‑related duties as assigned.

Requirements:

• The ideal candidate for this position has outstanding interpersonal skills. In addition to exceptional written and oral communication skills, the RQAS will be working with a variety of audiences to include research leadership, administrators, principal investigators, and research staff, and will need to be proactive in engaging relationships and building lines of communication to effectively generate and disseminate pertinent research communications.
• The candidate must also have no less than 3 years of clinical science research experience.

Education:

• Bachelor’s degree or greater in a Scientific Discipline, Business Administration, Health Care Administration or related field or four years of relevant work‑related experience in health care or medical/academic setting can be substituted in lieu of a degree.

Preferred:

• Master’s degree in a related field.
• Experience in compliance, research, patient relations, health care, medical/academic setting or communications.

Skills:

• Excellent oral and written communication skills.
• Computer proficient.
• Strong attention to detail.
• Strong data collection and analysis skills.

Supervision:

• Not required to supervise others.
• Customer Service:
• Takes routine or required customer actions to meet customers’ needs
• Responds promptly and accurately to customers’ complaints, inquiries, and requests for information and coordinates appropriate follow‑up.

Working Conditions:

• Work is performed in an office environment with pleasant working conditions.
• Eligible for a hybrid work arrangement following the successful completion of the probationary period.

Physical Requirements:

• Rarely required to exert physical effort.

Schedule:

• 8‑hour shift
• Monday to Friday

**Position located in Houston, TX. Relocation expenses are not covered.**