Job Description
- Protocol Development and Coordination
- Protocol Specific Training of Clinical Research Sites
- Oversight of Clinical Research Sites prior to and during study conduct
- Dissemination of study results
- Communication, Community Education, and Information Dissemination
- Provide scientific review and input into concept and protocol development.
- Collaborate with protocol team leadership to develop systematic methods of providing guidance to clinical research site teams on clinical management, ensuring consistency and harmonization across studies.
- Be knowledgeable of all assigned study protocols, including study drug profiles.
- Represent the Network in interactions with investigators and pharmaceutical manufacturers as needed
- Manage clinical queries for CoVPN mAb studies, per the requirements of the protocol, and ensure all queries from sites are resolved
- Review and identify trends and signals in study-specific clinical and laboratory events.
- Collaborate with protocol team leadership to create and revise regulatory documents that pertain to clinical management issue such as Serious Adverse Events (SAE) reporting.
- Collaborate with team leadership and statistical center on study monitoring committee/Data and Safety Monitoring Board review activities as they pertain to relevant clinical issues.
- Collaborate with protocol team leadership to conduct site trainings and re-trainings for clinical and safety management
- Keep abreast of relevant scientific literature and clinical trial designs to build capacity
- Serve as a resource for training of clinical and scientific topics to Network staff
- Assist with creating and/or reviewing abstracts, manuscripts and conference presentations as necessary
- Other duties as assigned.
- Medical Doctor (M.D or equivalent degree) or International Equivalent in Obstetrics and Gynecology, Family Planning, Public Health, or a Related Medical Specialty / Sub Specialty or equivalent related education and experience.
- Licensed MD; Board Certification in internal medicine, family practice or infectious diseases is preferred
- Typically requires 12+ years of experience to include internships, residencies, and fellowships
- Experience with non-governmental organization (NGO), research in academia, CRO, or pharmaceutical industry a plus.
- Experience working with infectious diseases, particularly respiratory diseases (treatment, prevention, related clinical research trials) preferred
- Comprehensive knowledge of theories, concepts and practices used in analysis of clinical research studies and clinical trials preferred.
- Demonstrated knowledge of medical clinical pharmacology.
- Knowledge of clinical research trial methodology and development process, regulatory requirements governing clinical trials preferred.
- Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects.
- Ability to handle multiple concurrent projects
- Ability to take initiative, demonstrating creative problem-solving skills and decisiveness.
- Ability to motivate, influence and collaborate with others across all levels of the organization.
- Excellent oral and written communication skills.
- High-level analytical skills to identify appropriate courses of action. Identifies potential risks to portfolio execution and recommends corrective actions.
- Identifies and incorporates constraints into the portfolio process and recommends solutions.
- Decisions and actions have a significant impact on management and division operations. Problems encountered are complex and highly varied.
- Exercises judgment to meet business strategies and develops objectives that align with organizational goals.
- The ability to sometimes work long hours on a computer or conference call.
- An employee needed for 50% or more time.
- Typical office environment. Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard. Ability to sit and stand for extended periods of time. Ability to lift 5 - 25 lbs
- <10%
- #LI-LW1
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Việc làm tại các tổ chức phi chính phủ - NGO Recruitment
- Website: https://ngorecruitment.org/
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- Group: https://www.facebook.com/groups/VieclamPhichinhphu
- Youtube: http://bit.ly/Youtube_NGORecruitment
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