Clinical Research Coordinator

Join a Stealth Mode Startup with Breakthrough Ultrasound Tech!Our Medical Device client is revolutionizing ultrasound imaging, pushing the boundaries with technology that will extend both the range and clarity of current systems. With FDA Device approval, they're gearing up for Clinical Trials.Hiring: Clinical Research Contract Coordinator (Ultrasound)As we advance our breakthrough technology, we're looking for a detail-oriented and experienced Research Contract Coordinator to join our team. This role will focus on managing research contracts for ultrasound studies, collaborating with hospitals, clinical sites, and internal teams to ensure smooth operations and compliance with regulatory standards.The ideal candidate will have a clinical research background, strong organizational skills, and the ability to manage research projects and relationships with hospitals and clinical sites.Key Responsibilities:Contract Management:Negotiate, draft, and review research contracts and budgets for ultrasound studies. Handle documentation, contracts, loan agreements, and MRAs.Ensure that contracts are accurately aligned with study protocols and institutional policies.Collaborate with legal and regulatory to ensure all contracts meet regulatory requirementsDevelop and maintain relationships with key vendors and stakeholders (e.g., external & contracts team and external & internal Clinical departments).Budgeting & Financial Management:Develop and manage study budgets, ensuring financial alignment with protocols and stakeholders.Ensure that project budgets align with contract terms, study protocols, and institutional guidelines.Regulatory Compliance & Documentation:Ensure all contracts meet regulatory requirements and maintain up-to-date records.Ensure compliance with GCP, IRB protocols, and research regulations (e.g., Sunshine Act).Track project-related expenses, ensure budget adherence, and prepare financial reports for stakeholders.Work closely with finance to ensure accurate billing and payment processes.Assist with invoicing, payments, and financial close-out processes at study completionStakeholder Collaboration:Build strong relationships with clinical sites, investigators, and sponsors.Serve as the point of contact for contract-related communications between investigators, sponsors, clinical teams, and administrative staff.Provide contract-related guidance and support to research staff and investigators, ensuring they understand contractual obligations and compliance requirements.Coordinate and participate in contract meetings, study kick-offs, and regular progress check-ins.Project Tracking: Monitor study timelines, milestones, and reporting to ensure success. Coordinate deliverables, follow up with sites, and report progress back.Benefits:Be part of a dynamic and innovative team that's shaping the future of medical imaging.Competitive salary depending on level ($90K - $190K), stock options, and excellent benefits (medical, dental, vision, 401(k)).Hybrid flex: Santa Clara, CACollaborate with top-tier professionals as we launch the next generation of ultrasound technology.Ideal Candidate Profile:Strong research coordination experience.Ability to work across multiple organizations and keep paperwork streamlined.A detail-oriented relationship builder who thrives in a regulatory environment.2+ years of medical device research contract management experience (preferably in ultrasound studies).Strong organizational skills, negotiation expertise, and familiarity with clinical trialsA passion for innovation and willingness to take on new challenges in a fast-paced, cutting-edge environment.Bachelor's degree in business administration, health sciences, or related field (advanced degree or clinical background a plus).Excited to be part of a disruptive, game-changing startup? Apply now and help us shape the future of ultrasound technology!Ultrasound #ClinicalResearch #MedTech #Innovation #FDAApproval #MedicalDevice #Startup #ContractManagement #ResearchJobs #Hiring

Created: 2025-01-31