Drive impactful clinical research projects in a remote role. Collaborate with global teams to manage trials and Early Access programs. Enhance your expertise in non-interventional studies and regulatory compliance.
Clinical Research Coordinator
in Healthcare + Life Sciences ContractJob Detail
Job Description
Overview
- Coordinate and manage clinical trials, Early Access programs, and investigator-sponsored studies across multiple regions.
- Ensure compliance with ICH GCP guidelines and country-specific clinical trial regulations.
- Develop and monitor study budgets, timelines, and resource allocation for clinical projects.
- Collaborate with cross-functional teams and external consultants to achieve project goals.
- Track and oversee clinical trial statuses using Clinical Trial Management Systems.
- Provide proactive solutions to complex clinical research challenges.
- Support healthcare professionals in navigating Early Access mechanisms.
- Contribute to strategic planning and operational setup of clinical studies.
Key Responsibilities & Duties
- Manage day-to-day activities of local, regional, and global clinical trials.
- Coordinate investigator-sponsored trials, including performance tracking and operational assessments.
- Lead cross-functional task forces for Early Access programs.
- Ensure quality and compliance in clinical trial execution.
- Develop and oversee budgets for clinical studies and Early Access programs.
- Manage external consultants and vendors, ensuring effective collaboration and training.
- Monitor clinical trial progress and resolve issues proactively.
- Facilitate medical reviews and coordinate supply chain processes for Early Access requests.
Job Requirements
- Bachelor of Science (BS) in Medical or Life Sciences or equivalent qualification.
- Minimum 5 years of experience in clinical research within CRO, pharma, or biotech sectors.
- Thorough knowledge of ICH GCP guidelines and clinical trial planning.
- Proven ability to manage budgets, timelines, and multiple tasks simultaneously.
- Strong analytical, interpersonal, and communication skills.
- Experience with Early Access Programs and non-interventional studies is highly preferred.
- Fluency in English and local language proficiency.
- Ability to navigate complex situations with a solution-oriented approach.
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