Regulatory and Start Up Specialist/Contracts and Budget Specialist

Summary

Join Precision for Medicine, a CRO that combines new technologies, expertise, and operational scale to accelerate the development of life-changing therapies. As a Regulatory and Start Up Specialist/Contracts and Budget Specialist, you will play a crucial role in site activation readiness, ensuring timely and high-quality delivery within assigned countries and sites. This fully remote position requires strong communication and organizational skills, experience in clinical research agreements, budget development, and fluency in English and Spanish. You will collaborate with various teams, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management, to ensure smooth project execution. Precision for Medicine values employee contributions and fosters a culture of innovation and positive change.

Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 1 year or more as a Regulatory/ SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Experience drafting, reviewing and negotiating agreements related to clinical research
• Experience developing and negotiating the budget
• Strong communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and Spanish

Responsibilities

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Maintenance of project plans and project trackers
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including site contracts and budget negotiation requirements
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department

Preferred Qualifications

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience
• Experience using milestone tracking tools/systems
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science