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Precision For Medicine स्वास्थ्य सेवा और जीवन विज्ञान क्षेत्र में सेवाएँ प्रदान करने वाला एक संगठन है, जो दवा और जैव-प्रौद्योगिकी कंपनियों को उपचार विकसित करने और उन्हें व्यावसायिक रूप से उपलब्ध कराने में सहायता करता है। इसके विशेषज्ञता क्षेत्रों में ऑन्कोलॉजी, दुर्लभ रोग और ऑटोइम्यून स्थितियाँ शामिल हैं। इसका कार्य नैदानिक परीक्षण प्रबंधन, प्रयोगशाला सेवाएँ, जैव-नमूना संग्रह, बायोमार्कर संबंधी क्षमताएँ और विनिर्माण सहायता को जोड़कर जटिल विकास कार्यक्रमों का समन्वय करता है। नैदानिक अनुसंधान प्रक्रिया के दौरान इन सेवाओं को एकीकृत करके Precision For Medicine टीमों को परिचालन संबंधी चुनौतियों से निपटने और संभावित उपचारों को रोगियों तक पहुँचाने की दिशा में आगे बढ़ने में सहायता करता है।
Regulatory and Site Start-Up Specialist - Australia Remote
Support clinical trial submissions and site activation for Precision For Medicine, a life sciences CRO. Manage essential documents, ethics approvals, contracts, and country-specific regulatory compliance.
विवरण
- Coordinate timely, high-quality site activation readiness across assigned countries and sites while identifying and mitigating risks.
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other relevant local bodies.
- Communicate with Competent Authorities and Ethics Committees and manage their responses.
- Provide recurring submission updates to Start-Up or Regulatory Leads and Project Managers or Project Teams.
- Maintain project plans, tracking tools, and regulatory intelligence systems.
- Help develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
- Work with assigned site CRAs to coordinate communication and build site collaboration.
- Prepare, review, and manage essential documents for site activation and IMP release.
- Adapt country- and site-specific Patient Information Sheets and Informed Consent Forms.
- Coordinate document translation requirements and related activities.
- Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.
- Serve as the subject matter expert for site-level critical-path and site-activation data.
- Assist with study budget negotiations and investigator contract execution when needed.
- Support feasibility outreach to potential sites as required.
- Keep current with local clinical trial laws and regulations and share relevant knowledge internally.
- Maintain audit and inspection readiness and file documents in line with TMF and study-specific plans.
- Assist with Pre-Study Site Visits when required.
- Contribute to process improvements, training, and mentoring.
- Complete additional duties assigned by management.
आवश्यकताएँ
- Bachelor’s degree in life sciences or a related discipline, Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.
- At least one year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotech role, with equivalent relevant experience or demonstrated competencies also considered.
- Strong communication and organizational abilities.
- Experience with computerized information systems, electronic spreadsheets, word processing software, and email.
- Fluency in English and, when applicable, the local language of the country where the role is based.
- Legal authorization to work in the employment country without employer sponsorship.
- Preferred: regulatory and site start-up experience relevant to the specific country.
- Preferred: experience with milestone tracking tools or systems.
- Preferred: ability to prioritize work and meet deadlines.
- Preferred: advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.
लाभ
- Regular full-time employment.
- Equal Opportunity Employer.
- Reasonable accommodations are available for applicants with disabilities.
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