What are the responsibilities and job description for the Study Start Up position at Actalent?
Job Description:
- Manages regulatory activities for all stages of clinical trials for assigned department.
- Prepares and submits regulatory documents to the Sponsor and IRB and works with the clinical research team to ensure submission documents are up-to-date.
- Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials.
- Prepare and submit start-up regulatory packets to the Sponsor and IRB.
- Oversee study start-up activities, including reporting and communicating with stakeholders on a regular basis
Required Skills & Qualifications:
- Completion of a Bachelor's in a scientific discipline (e.g. Life science, Engineering, Nursing, Medicine, etc.) is preferred.
- A minimum of 5 years of related job experience in site start-up, regulatory, contract management, ethics submission, is required.
- Experience with a centralized IRB (Advarra or WCG) is required.
- OnCore experience is preferred.
- Oncology experience is preferred.
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 : $35 - $40
