PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The IRB Analyst manages and/or conducts the confidential review and approval process of proposed research activities involving human subjects at Children’s Hospital of Wisconsin. The IRB Analyst must understand many complex and sometimes disparate regulatory and ethical issues and how they apply to CHW research. Balance the need to assure CHW’s compliance with different federal regulations, the need to facilitate research, while also addressing ethical considerations.
ESSENTIAL FUNCTIONS (In order of importance):
Exhibits guiding behaviors that reflect Children’s values and support our mission and vision.
Qualified and may be required to independently perform all duties of IRB Coordinator.
Serves as ex-officio voting member of CHW IRBs.
With moderate direction, oversees and guides reviews of research that involves more than minimal risk conducted by the convened IRB. This includes: (1) thorough pre-review of all submitted materials to ensure that the materials provide all information required for the IRB to make required regulatory determinations; (2) write emails to the researcher that quickly, accurately, and intelligibly communicate the information needed to move the study forward; (3) identify for the IRB all regulatory issues and required determinations; (4) identify whether a consultant is needed to supplement the IRB's expertise; (5) write letters to the researcher that accurately and intelligibly communicate the IRB's determinations, questions, and conditions for approval; (6) accurately capture for required meeting minutes the IRB's deliberations and determinations; (7) verify on behalf of the IRB that conditions of approval have been met.
Conducts and documents expedited IRB reviews of human subject research, according to all applicable federal, state and local criteria for approval. Includes making decisions about whether waivers of specific regulatory requirements are appropriate and allowable under the applicable regulations. Individual is IRB Chair designee delegated to approve certain limited actions.
Conducts preliminary review of all unanticipated problems involving risk to subjects or others, noncompliance reports, and new information to determine whether a risk mitigation or corrective and preventive action plan is required and reviews with Research Integrity Manager prior to recommending action.
Establish and manage IRB reliance and external IRB agreements, as well as the front-end and back-end processes that support these agreements.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Bachelor's degree in biomedical, health science, social sciences or related field plus three years of experience with IRB and/or research regulations.
Certified IRB Professional (CIP) or Certified IRB Coordinator/Manager (CIC/CIM) preferred.
An equivalent combination of education and/or experience may substitute for the stated requirements and will be considered.
The IRB review process is largely conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between screens to obtain and synthesize information.
Strong analytic skills and ability to manage multiple, complex activities while maintaining close attention to detail and meeting required timeframes.
Sound judgment, excellent problem-solving, organizational, and time management skills.
Excellent customer service, proofreading, prioritization and interpersonal skills.
Excellent oral, written, and electronic communication skills, able to interact with a wide range of professional levels.
Highly organized, detail oriented, and be able to work both independently and collaboratively in a team environment, which may include remote colleagues.
Ability to work autonomously in a fast-paced, dynamic, and ever-changing environment.
Personal computer experience using word processing software, databases, and Adobe.
Internal Number: 30949
About Children's Hospital of Wisconsin
At Children’s Hospital of Wisconsin, we believe kids deserve the best.
Children’s Hospital is a nationally recognized health system dedicated solely to the health and well-being of children. We provide primary care, specialty care, urgent care, emergency care, community health services, foster and adoption services, child and family counseling, child advocacy services and family resource centers. Our reputation draws patients and families from around the country.
We offer a wide variety of rewarding career opportunities and are seeking individuals dedicated to helping us achieve our vision of the healthiest kids in the country. If you want to work for an organization that makes a difference for children and families, and encourages you to be at your best every day, please apply today.