Job Summary:

The Clinical Trails Specialist (Cancer Center Focus) will be the point of contact for review, preparation, processing, and negotiation of Clinical Trial Agreements (CTAs), including budgets, with priority given to Cancer Center activities. Additional duties include but are not limited to: review and negotiate CTAs and budgets with sponsors, CROs, and research departments, ensure compliance with institutional policies, federal regulations, and sponsor requirements, collaborate with legal, hospital finance, and clinical operations teams to resolve contract issues and discrepancies. Develop and maintain contract templates and standard operating procedures (SOPs), track contract status and timelines to ensure timely execution, provide guidance and training to research staff on contract and budget-related matters, assist in the development of study budgets and financial plans and maintain accurate records of contract negotiations and final agreements.

This role will also provide ongoing education and mentorship to CRAs to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and sponsor expectations and collaborate with clinical teams to identify training needs and implement continuous learning initiatives to enhance research quality and efficiency.

Minimum Qualifications:

Bachelor's degree in a related field (e.g., Business, Law, Healthcare, Science) at least 3 years of experience in clinical research contract review and negotiation or an equivalent combination of education and experiance.  Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial budgeting. Excellent negotiation, communication, and interpersonal skills.

Preferred Qualifications:

Master's degree in a related field. Certification (e.g., ACRP, SOCRA) or willingness to obtain.

Work Days:

M-F Days

Message to Applicants:

Salary Range-$65,000-$85,000

Recruitment Office: Human Resources