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Careers
Schulman Associates IRB is dedicated to human research subject protection. From its beginnings in 1983, Schulman has grown to one of the most prominent independent IRBs in the country, recognized as a technology and customer service leader. We believe our successes are a direct result of the talented group of professionals we employ and their unwavering attention to the needs of each and every client.In addition to a full benefits package, we offer our employees a challenging, dynamic and rewarding work environment. If you would like to explore employment opportunities at Schulman, please send your resume and cover letter to Human Resources.
Currently, we are hiring for the following positions:
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This position is responsible for medical leadership and support of Board review functions. This position works with the CEO, IO, the Director of Board Operations, and the Board Chair(s) setting the short-term and long-term objectives that ensure the Board effectively fulfills its obligation to protect human research subjects.
Education/Training/Experience Required:
- Board certified MD, or equivalent
- Active Medical License
- Minimum of 5 years experience in regulatory affairs in clinical research or in conduct of clinical research
- Knowledge of Human Subject Protection regulations and guidances
- Knowledge of Institutional conflict of interest policies and guidances
- Knowledge of AAHRPP and Canadian regulatory requirements
- Previous experience on an IRB
- Prior membership in research related professional organizations
Knowledge/Skills/Abilities Required:
- In-depth knowledge of clinical research, including, but not limited to, pharmaceutical and device trials
- Comprehensive knowledge and understanding of FDA and OHRP regulations and ICH Guidance for institutional review boards
- Ability to research and analyze regulations and guidance and to provide recommendations
- Adheres to high ethical standards
- Demonstrated leadership skills
- Advance oral and written communication skills
- Ability to facilitate group discussion
- Excellent relationship-building skills
- Ability to work independently and in collaboration with internal and external clients to develop solutions to complex problems
- Ability to multi-task, managing conflicting demands and priorities
- Attention to detail with a high level of accuracy
- Demonstrated consistency and dependability in quality and quantity of work
| This position is responsible to provide analysis and advice on legal, regulatory and policy issues pertaining to the organization's and Board's role in the protection of human research subjects.
Education/Training/Experience Required:
- Juris Doctor required
- 3 years legal experience required, 5 years IRB legal experience preferred
- Intermediate to advanced computer skills, including experience with MS Office products
- Must be licensed to practice law
Knowledge/Skills/Abilities Required:
- Knowledge of clinical research, including but not limited to pharmaceutical and device trials preferred
- Knowledge and understanding of FDA and OHRP regulations and ICH Guidance for institutional review boards
- Ability to research and analyze laws, regulations and guidance and provide recommendations
- Advance oral and written communication skills
- Excellent relationship-building skills with customers, vendors and members of Schulman organization
- Ability to work independently and in collaboration with internal and external clients to develop solutions to complex problems
- Ability to multi-task, managing conflicting demands and priorities
- Attention to detail with a high level of accuracy
- Demonstrated consistency and dependability in quality and quantity of work
| This position is responsible for the management of multiple projects according to assigned clients. The primary objective is to manage the operational process and client relationship in order to deliver services that meet customer needs and business objectives.
Education/Training/Experience Required:
- Minimum one year administrative experience in a research based setting
- Moderate computer skills and working knowledge of Microsoft Word, Excel and Outlook
- Basic mathematical ability, including calculation of figures and payment amounts
- High School Diploma required, bachelor's degree preferred; or a minimum of 2 years administrative experience
Knowledge/Skills/Abilities Required:
- Ability to work independently; planning, organizing, scheduling and completing work within deadlines
- Excellent interpersonal skills to work effectively with others and provide high levels of customer service
- Must be detail-oriented and possess mathematical and analytical skills
- Ability to multi-task, establishing and managing conflicting demands and priorities
- Ability to communicate effectively verbally and in writing
| This position provides support in the ongoing conduct of the organization's quality assurance program. The primary focus is maintaining accurate and consistent documentation of the organization's training and continuous quality improvement initiatives.
Education/Training/Experience Required:
- High school diploma required, BA/BS strongly preferred
- Basic computer skills. Including experience with MS Office products
Knowledge/Skills/Abilities Required:
- Exceptional attention to detail, accuracy and thoroughness
- Reliable documentation practices and solid organizational skills
- Ability to multi-task, managing conflicting demands and priorities without compromising quality
- Effective written and verbal communication skills
- Cultivate effective working relationships with all members of the Schulman organization
- Ability to utilize common software such as Word, Excel, Access, and PowerPoint and to learn new software as required
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