Clinical Research Professional

4 weeks ago


Alameda, California, United States Actalent Full time

Actalent is a global leader in engineering and sciences services and talent solutions, driving scale, innovation, and speed to market for visionary companies. Located in a remote setting, this role is an excellent opportunity to advance your career as a Clinical Research Professional.

Job Description:

This Clinical Research Professional role is responsible for reviewing scientific data and developing product knowledge to understand and communicate relevant information for one or more clinical studies. The ideal candidate will have key relationships internally with the clinical project (study) team and other study stakeholders.

Responsibilities:

  • Review scientific data and develop product knowledge to understand and communicate relevant information for one or more clinical studies.
  • Develop and review various study protocols with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring a high-quality final document.
  • Prepare and present reports and presentations on the findings of clinical research.
  • Regularly review information to check safety procedures, efficiency, and the lab data's accuracy and correctness.
  • Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR.
  • Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant study materials.
  • Collaborate with all study team members including Clinical/Medical Affairs, Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors.
  • Meet deadlines and milestones required based on assigned study goals.

Requirements:

  • 5 years of data review experience.
  • 3+ years of data review in oncology.
  • Experience with TFL Review.
  • Medical Safety Data Review.
  • Results evaluation/review.
  • Completed Master's degree or higher.

Salary: $80,000 - $110,000 per year, depending on experience.

Benefits:

  • Competitive salary.
  • Benefits package.
  • Opportunities for growth and professional development.

About Actalent:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We maintain an inclusive environment through persistent self-reflection and build a culture of care, engagement, and recognition with clear outcomes. We are 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.



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