Biorepository & Laboratory QA/QC Specialist- BPC Arlington

The Biopathology Center (BPC) within The Research Institute at Nationwide Children’s Hospital (NCH) is a primarily grant-funded biorepository and clinical laboratory with the objective of acquisition and long-term storage of a large number of cancerous, normal and diseased biospecimens and related data. These biospecimens are used for the purpose of supporting and facilitating cutting edge research and advancing clinical patient care. In accordance with provisions of approved protocols, the BPC serves as biorepositories for the Children’s Oncology Group (COG), NRG Oncology, SWOG (formerly the Southwest Oncology Group), the Pediatric Division of the Cooperative Human Tissue Network (pCHTN), Experimental Therapeutics Clinical Trials Network (ETCTN), and other sponsor groups. This is a fast-paced, team-oriented laboratory that requires the ability to work well under pressure and maintain constant attention to detail. The Biorepository and Laboratory QA/QC Specialist is responsible for contributing to the BPC’s quality program, including quality control, documentation review and management, process improvement, and monitoring key metrics and overall quality. This role also serves as a resource for others in the department regarding the College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) and CAP Biorepository Accreditation Program (BAP) guidelines, regulations, and laws.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose.

Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

We’re 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children’s Hospital. A Place to Be Proud.

Responsibilities

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Participates in all activities relating to the College of American Pathologists’ (CAP) Biorepository accreditation; interprets and facilitates accreditation program standard as it applies to Biopathology Center staff and all laboratory and non-laboratory areas.

Assists with the drafting, review, and revision process for all BPC standard operating procedures/policies; this includes, but is not limited to: scheduled reviews by process expert(s); significant updates/revisions; initiating revisions following a process improvement effort, or researching best practices; etc. Maintains both electronic and hard copies of all documents.

Coordinates, tracks, and organizes required training and competency documentation for all (100+) BPC employees. Participates in orientation and prepares all materials for new and transferred employees.

Presents staff education informational sessions for relevant safety, compliance, or other relevant regulatory topics, including human subjects training and IATA shipping regulations.

Schedules and performs regular audits, including laboratory safety, quality improvement, inspection preparation, and other relevant audits; methods may include a review of documents, observation, or staff performance. Supports management and other staff with other site visits/audits, as necessary.

Contributes to CAP site inspections, including attending inspection preparedness meetings with all relevant internal staff; facilitating, scheduling, and drafting documents for the self-inspection; and on-site inspection readiness.

Consistently maintains CAP and clinical research regulatory binders in an “audit ready” status.

Maintains current knowledge of research regulations, CAP LAP and BAP requirements, safety, and other applicable laws, regulations, and requirements by reviewing current publications and attending relevant conferences and meetings. Maintains working knowledge of current processes and procedures in the BPC and advises BPC management of any changes that may impact BPC operations and recommends appropriate actions.

Coordinates regular evaluation of quality assurance/quality control plans and strategies, which may include analysis of documented incident reports and review of related research and best practices; based on these findings, recommends changes, corrective actions, and/or future prevention to BPC Management as appropriate.

Participates in and contributes to regulatory reporting and submission of related documents to appropriate regulatory review committees, including IRB protocol continuing reviews of IRB protocols or amendments, safety reports, and other regulatory reports as required.

Reviews associated specimen submission documentation and verifies accuracy of data entry. Reads pathology reports to verify disease type and tissue type.

Researches and applies knowledge related to continuous quality improvement through reviewing publications, attending conferences, and networking with other research institutes.

Serves as a primary resource for all BPC management and staff for all relevant regulatory, compliance, and safety topics; researches industry standards for new processes or emerging technologies.

Demonstrates knowledge of and upholds applicable laws and regulations related to position. Maintains knowledge of techniques, procedures, and protocols, lab-wide and within lab section. Reviews and acknowledges policies and procedures as required.

Demonstrates the ability to communicate respectfully with coworkers, staff, sponsors, and clients. Continuously be provide excellent customer service in an efficient and effective manner to assure customer satisfaction and quality patient care.

Maintains a safe environment. Wears appropriate personal protective equipment as designated by lab area. Reports spills and hazardous situations immediately and acts appropriately. Follows established guidelines for disclosure of patient information.

Assists in process development/improvement within the department including participating in quality assurance, continuing education programs, and department meetings.

Demonstrates the initiative and ability to provide feedback that is useful and assists in individual improvement. Promotes a cohesive work environment and possesses a solution-driven mentality.

Demonstrates the ability to make determinations regarding course of action and alternatives by addressing problems by using resolutions and basic troubleshooting skills.

Performs other duties as assigned or required.

Qualifications

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

Bachelor’s degree in science preferred (bachelor’s degree in other specialties will be considered with sufficient years of experience in a clinical laboratory, biorepository, or similar environment) with at least three to five years of experience, including biorepository/laboratory, or quality control/quality assurance and troubleshooting in a similar laboratory setting. Previous CAP/CLIA or CAP BAP experience preferred.

Experience in clinical trials, preferably oncology (patient or sample coordination) preferred.

Knowledge of federal regulations including, National Institute of Health (NIH), Department Health and Human Services (DHHS), Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) study protocols and IRB policy preferred. 4. Experience with document control, including a document and record management system application preferred (e.g. Q-Pulse).

Strong written and verbal communication skills, as well as excellent interpersonal skills, are required to facilitate effective communication with all staff. 6. Demonstrates the ability to adjust to change, handle interruptions and function with changing circumstances.

Excellent organization and time management/prioritization skills with the ability to work both independently and with specific direction on a diverse and demanding workload.

Good analytical skills, and attention to detail; objectivity; ability to extrapolate regulations and requirements to various situations; demonstrated problem-solving skills.

MINIMUM PHYSICAL REQUIREMENTS:

Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time. Good visual and auditory acuity.

Full use of hands and arms. Ability to speak clearly.

Ability to lift up to 30 pounds occasionally. Must complete color blind testing.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.

It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE/M/F/Disability/Vet.

Full Time