Senior Specialist Research Compliance (Tissue Culture Lab Quality Assurance)

DEPARTMENT: Office of Research Compliance and Regulatory Affairs (ORCRA)

SUPERVISOR'S TITLE: Manager-Research Compliance

TITLES SUPERVISED: Coordinator-Research Compliance



Summary: This position will support (1) manufacturing viral vector or genetically manipulated cells or (2) product or sample analysis for subjects in clinical trials conducted under early phase INDs. All work must comply with 21CFR210/211 (Good Manufacturing Practices and/or 21 CFR1271 (Good Tissue Practice) and, correspondingly, must be performed under defined quality systems and must be reviewed by quality compliance personnel reporting independently of the manufacturing leadership.

PURPOSE OF POSITION: Coordinate & lead institutional research compliance functions in accordance with regulatory standards within assigned program area (including but not limited to human subjects research, GMP, GLP, GTP, research compliance, biosafety, etc.). Collaborate with clients to develop positive and proactive approaches to regulatory compliance. Participate in all required training related to assigned program area and develops training sessions as needed. Manage interactions during regulatory agency inspections. Direct interaction with regulatory agencies on defined matters. Recommend strategies for improvement of research operations. Implement corrective action.

·Regulatory Knowledge and Oversight
Independently interpret and analyze the concepts and principles of federal and state law, institutional policies/procedures/guidance and professional guidance as it relates to the review and oversight of research and assess the impact of specific regulatory decision on the overall research environment at CCHMC.
·Institutional Support
Serve as an institutional content area expert in assigned program area related to research compliance/oversight.
Function as a contributing member of the team with the ability to lead departmental initiatives and take on key roles on departmental and institutional initiatives. Mentor for more junior ORCRA staff. Routinely responsible for developing and/or delivery education/training content for both internal and external audience
·Policy & Procedure Development
Recommends and writes procedures. Review and approval of supporting regulatory documents to ensure compliance to the regulations, policies and procedures
·Quality Improvement
Analyze trend data. Identify the opportunities for Quality Improvement based on metrics and trends of results.

Skills & Competencies
Ability to accurately document as necessary
Using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.
·Data Management - Advanced
Advanced knowledge of data management methodologies and technology
·Quality Improvement
Sound understanding of concepts of quality improvement; capable of developing, implementing, monitoring and acting on quality assessment and improvement controls
·Diversity Appreciation
Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself
·Interpersonal Skills - Adv
Strong interpersonal skills. Effectively communicate at all levels of the organization.
·Knowledge of Field - Intrm
Knowledge of regulations, procedures and best practices in field
·Decisive Leadership
Taking responsibility for guiding others' actions and providing direction to a group; stepping forward to take the lead in addressing difficult issues and making tough judgment calls
·Computer Proficiency
Proficiency in basic computer applications such as Microsoft Office (PowerPoint, Word, Excel), e-mail, and internet
·Detail Orientation
Meticulously keeping track of details without becoming overwhelmed by them; being exacting, precise, and accurate; spotting minor imperfections or errors and taking action to correct them
·Independence and Teamwork
Ability to work autonomously, with independent judgment, as well as in a collaborative team environment.
Strong organizational and project management skills to handle projects independently.
·Professional Demeanor
Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
·Analysis - Basic
Analytical ability sufficient to evaluate data, make judgments and recommendations
·Critical Thinking
Using inductive and deductive reasoning to formulate general rules or principles and apply them to work; identifying flaws in logical reasoning; understanding complex conceptual relationships; accurately detecting underlying themes or patterns in data
·Problem Solving
Ability to independently work through details of a problem to reach a positive solution
·Research Methods - Advanced
Designing and conducting effective research studies that address measurement, data collection, and validity issues; identifying or developing appropriate, accurate, relevant, and reliable measurement methods; drawing appropriate conclusions from study results
Excellent verbal, written and/or interpersonal communication skills

·Bachelor's degree AND 5 years related experience OR
·Master's Degree AND 3 years related experience
·For Research Compliance Program (RCP) Certified Quality Auditor (CQA) Registered Quality Assurance Professional Certified Quality Manager (CQM) OR Regulatory Affairs Certified-RAC, or similar applicable certification within 2 yrs
-10% Domestic Travel
-Quality assurance auditing experience in a pharmaceutical setting
·Experience in an academic or research institution