IBC responsibilities include management of the day to dayoperations of the IBC, including overseeing the IBC protocol review process, providingregulatory review of biosafety protocol applications, amendments, and assistingwith protocol reviews and process, maintaining meeting minutes and records, andassisting the IBC chair and IACUC/IBC Compliance Manager in consulting withResearchers and staff to improve and assure compliance with local, state andfederal laws and regulations.
In supporting IACUC, the responsibilities include overseeingIACUC protocol reviews and processing, coordinating semi-annual inspections andprogram reviews, assisting researchers in developing IACUC protocols,supporting IACUC to investigate and address noncompliance, performingcongruence reviews between research grants and IACUC protocols, and assisting theIACUC/IBC Compliance Manager and IACUC chair in managing all aspects ofregulatory compliance for vertebrate animal use in research.
General Description: Performs the coordination and preparation of institutional research compliance functions in accordance with regulatory standards within assigned program area (including but not limited to human subjects research, vertebrate animal research, GMP, GLP, GTP, research compliance, biosafety, etc.). Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in all required training related to assigned program area and assists in the development of training sessions as needed. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest for improvement of research operations. Assists with the corrective action implementation.
·Regulatory Knowledge and Oversight
With limited direction from more senior ORCRA staff and within a limited and clearly defined scope, broadly apply the concepts and principles of federal and state law and institutional policies/procedures/guidance to review and oversight of research.
Serve as content area expert within a specifically defined program area related to research compliance/oversight.
Function as a contributing member of the team with the ability to take on key roles on departmental initiatives. Learn from others in preparation for greater responsibility. Provide content for more broad educational programs
·Policy & Procedure Development
Assists in the creation of procedures.
Input data for trends. Assist in identifying the opportunities for quality improvement based on metrics and trends of results.
Ability to accurately document as necessary
Advanced ability to interpret, implement and develop policies and procedures
·Communication - Intermediate
Good verbal, written and/or interpersonal communication skills
Locating and gathering relevant information; recognizing and working to eliminate important gaps in existing information; determining the value of the information; synthesizing and organizing information to get a better understanding of a problem
·Data Entry - Advanced
Advanced data entry and keying skills
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
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
Proficiency in basic computer applications such as Microsoft Office (PowerPoint, Word, Excel), e-mail, and internet
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.
Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
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
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