|Title:||IRB Services Specialist|
|Job Status:||Full-time, Benefited|
Celerion is hiring an IRB Services Specialist to join the team. Are you looking to use your experience in clinical research in a new way? Do you have experience with medical terminology? Are you a person who loves the details? If so, we can’t wait to learn more about you.
Location: Our headquarters are in Lincoln, NE, just south of downtown.
You will coordinate activities pertaining to the regulatory review and submission of study documents to IRBs as part of the clinical research process. Write informed consent forms consistent with Institutional Review Board (IRB) requirements, Federal Regulations, and ICH guidelines.
- You will facilitate the IRB submission process to ensure all submission documents are complete and IRB approvals are received
- You will be responsible for informed consent development to include:
- Planning and executing all informed consent form and IRB activities for assigned projects on-time and error-free
- Making changes to informed consent form as needed throughout the life of the project
- Communicating with sponsors to obtain approval of informed consent form and changes
- Identifying protocol inconsistencies and communicate to appropriate associates and sponsors
- Updating and maintain informed consent form templates
- Interpret and apply institutional and federal policies and procedures regarding research in human subjects
- Provide internal Quality Control to the team
- Medical degree (LPN, RN etc.) or Bachelor’s degree preferred
- General knowledge of the clinical research industry
- Knowledgeable about regulatory requirements (including part 50 of Title 21of the Code of Federal Regulations
- Experience in organizing and managing multiple priorities
- Excellent oral and written communication skills
We are an equal opportunity employer
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Please apply online at www.celerion.com.