What are the responsibilities and job description for the Clinical Research Regulatory Coordinator position at Actalent?
Description:
Responsibilities
Primary responsibilities include IRB Submission to internal and external IRBs, assisting with sponsor investigator FDA submissions, regulatory binder creation, maintenance, and monitor visit support. The regulatory team works closely with the study teams to ensure that clinical trial research studies and documentation are properly maintained during the pre-IRB, IRB, and post-IRB submission phase.
IRB Submissions and Document Maintenance:
• Preparation of study documents for initial IRB submission, modification, and annual submission responsibility
• Protocol amendments and modifications to study documents including but not limited to informed consent form, Investigator's Brochure, recruitment materials, personnel changes, continuing review/study close‐ out, annual study, and maintenance reports
• FDA/regulatory document preparation (1572, FDFs, signature pages, etc.)
• Regulatory binder creation
• Interface with study team, sponsor, CRO (if applicable), IRB of record, and FDA (if applicable)
• Regulatory coordinators work with the study teams, PI, or Sub-I to ensure that any document that needs a signature are obtained in a timely manner. The file will be saved and/or sent back to the sponsor for proper filing.
• Sponsor required documentation and training log paired with amended modifications
Skills:
Regulatory, Clinical research, Irb, Regulatory documents, Gcp, Regulatory submission
Top Skills Details:
Regulatory,Clinical research,Irb,Regulatory documents,Gcp
Additional Skills & Qualifications:
-Someone who has 1 year as a Clinical Research Coordinator OR a Clinical Research Regulatory Coordinator. If they are a coordinator, they need to be doing all of the IRB submissions for their studies.
-Need to have experience with drug studies or medical device trials
-they will be submitting to both local and central IRB
-Oncology experience is preferred
Qualifications
•Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience
•General knowledge of protocol design. Attention to Detail Consistently displays accuracy and attention to detail
•Organization Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
•Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines
•Computer literacy in word processing database use, and file management
•Ability to work as part of a team
Experience Level:
Entry Level
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
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $27 - $31
