The Legal Specialist supports the Legal Department in providing efficient, accurate, and timely legal and administrative assistance related to the Company’s clinical research operations. The role contributes to contract management, corporate governance, regulatory compliance support, and legal documentation, in alignment with applicable laws, regulations, and internal policies governing clinical research activities.
More specifically, the legal specialist must:
- Assist in the preparation, review, coordination, and administration of contracts related to clinical research activities, including but not limited to: Clinical Trial Agreements (CTAs) , Confidential Disclosure Agreements (CDAs) , Vendor and consultant agreements , Amendments and contract addenda
- Coordinate contract execution workflows, including tracking signatures, versions, and approvals.
- Maintain and update contract databases, trackers, and document management systems.
- Support legal compliance activities related to clinical trials, including documentation required for audits, inspections, and due diligence processes.
- Conduct legal and regulatory research related to healthcare, clinical research, data protection, and corporate law as required.
- Privacy compliance support, completing and tracking privacy assessments, DPIAs, and other required documentation.
- Support the Legal Department in responding to internal inquiries related to contracts, policies, and legal processes.
- Assist in the development, updating, and organization of legal templates, SOPs, policies, and training materials.
- Liaise with internal stakeholders (Clinical Operations, Finance, Procurement, HR, Quality, etc.) to ensure timely and accurate legal support.
- Coordinate with external counsel, notaries, and regulatory bodies when required.
- Ensure confidentiality, accuracy, and compliance with applicable regulations (e.g., GCP, privacy laws, contractual obligations).
- Diploma or certificate in Paralegal Studies or equivalent legal training.
- Minimum of 3–5 years of experience as a paralegal or legal assistant, preferably in a CRO, pharmaceutical, biotech, or regulated environment.
- Different combinations of relevant education and work experience will be considered
- Strong understanding of contract administration and legal documentation.
- Familiarity with clinical research operations, GCP, and regulatory frameworks.
- Excellent organizational skills with strong attention to detail.
- Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Strong written and verbal communication skills in English.
- High level of discretion and professionalism when handling confidential information.
- Proficiency with Microsoft Office and contract/document management systems.
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What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
