Actalent
Regulatory Coordinator
Actalent, Des Moines, Iowa, United States, 50319
Job Title: Regulatory Coordinator
Job Description
Maintaining regulatory documents in accordance with site SOPs
Preparation of study level IRB/regulatory documents from approved templates
Assisting site with IRB submissions
Serve as the primary contact for clinical research associates and study monitors
General assistance with site initiation needs
Other duties related to regulatory support management as directed by the site investigator
Specific duties may include maintaining regulatory documents in accordance with site SOPs, preparation of study level IRB/regulatory documents from approved templates, and general assistance with site initiation needs. The dedicated resource provides and maintains an overall sense of urgency and emphasis on the sites studies.
Can also be the primary point of contact and coordination , creating site-specific source documentation, or managing the submission of IRB/regulatory documentation.
CTA/budget negotiations on behalf of the site are out of scope.
Essential Skills
Experience as a Regulatory Coordinator (2+ years).
Budget negotiations (2+ years).
IRB submissions (2+ years).
NEED: Experience working with Florence and Oncore
CITI Certifications
Work Environment
This position operates during normal business hours in a fast-paced environment that requires attention to detail.
Monday-Friday Schedule.
12 Month ContractAbout Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Job Description
Maintaining regulatory documents in accordance with site SOPs
Preparation of study level IRB/regulatory documents from approved templates
Assisting site with IRB submissions
Serve as the primary contact for clinical research associates and study monitors
General assistance with site initiation needs
Other duties related to regulatory support management as directed by the site investigator
Specific duties may include maintaining regulatory documents in accordance with site SOPs, preparation of study level IRB/regulatory documents from approved templates, and general assistance with site initiation needs. The dedicated resource provides and maintains an overall sense of urgency and emphasis on the sites studies.
Can also be the primary point of contact and coordination , creating site-specific source documentation, or managing the submission of IRB/regulatory documentation.
CTA/budget negotiations on behalf of the site are out of scope.
Essential Skills
Experience as a Regulatory Coordinator (2+ years).
Budget negotiations (2+ years).
IRB submissions (2+ years).
NEED: Experience working with Florence and Oncore
CITI Certifications
Work Environment
This position operates during normal business hours in a fast-paced environment that requires attention to detail.
Monday-Friday Schedule.
12 Month ContractAbout Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.