Associate Regulatory and Start Up Specialist III

Precision for Medicine is not your typical CRO. At Precision for Medicine, we have combined new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients. What sets us apart is how we integrate clinical trial processes with deep scientific knowledge, laboratory expertise, and advanced data sciences.

As our organization continues to grow, we are hiring an Associate Regulatory and Start Up Specialist I / II to join our team in Spain. This position can be offered fully remote.

Job Description

Position Summary :

The (Associate) Regulatory and Start Up Specialist I / II is an entry-level professional responsible for regulatory and site startup activities. Responsibilities, which depend on the location of the RSS, include but are not limited to : initial and subsequent clinical trial submissions to Competent Authorities and IRB / Ethics Committees, review and adaptation of Informed Consent Forms, collection and review of essential documents, supporting site submissions, and assisting the Site Contract Management group in budget and contract negotiations. The role is guided by a senior RSS and supported by other in-country team members involved in site startup activities.

Essential functions of the job include but are not limited to :

• Ensuring timely and quality delivery of site activation within assigned countries / sites, including risk mitigation.
• Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments) for approval by local authorities, complying with local and international regulations, SOPs, and ICH-GCP principles.
• Engaging with authorities for study purposes and managing responses.
• Providing updates on submissions to the Start Up Lead, Regulatory Lead, Project Manager, and Project Team.
• Maintaining project plans, trackers, and regulatory intelligence tools relevant to responsibilities.
• Supporting the development of startup plans, IMP release requirements, and document review criteria.
• Partnering with site CRAs to ensure alignment and collaboration.
• Managing collection and review of essential documents for site activation and IMP release.
• Customizing country-specific Patient Information Sheets and Informed Consent Forms.
• Overseeing translation of documents as needed.
• Communicating with key functions involved in country startup activities.
• Tracking critical path data points for site activation, including timelines and negotiations.
• Supporting budget and investigator contract negotiations as directed.
• Participating in site outreach for feasibility assessments.
• Staying informed of local clinical trial laws and regulations, and promoting compliance.
• Maintaining audit / inspection readiness and proper document filing.
• Performing other duties as assigned.

Qualifications : Minimum Required :

Other Required :

Preferred :

Additional Notes

Any data provided during the application process will be stored according to our Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. We do not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.

J-18808-Ljbffr