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Clinical Trial Protocol Writer (Contr...

This listing was posted on The Resumator.

Clinical Trial Protocol Writer (Contractor)

Location:
Oxford, Oxon
Description:

Location: Remote (Must be in UK / European / African time zone) Duration: Short term contract, ongoing basis as and when required Our Mission: The Ellison Institute of Technology (EIT) works to develop and deploy advanced technology in pursuit of solving some of humanity’s most challenging and enduring problems. Guided by world leaders, scientists, and entrepreneurs, EIT seeks to accelerate innovation by driving scientific and technological advancements across four humane endeavours: health and medical science, food security and sustainable agriculture, climate change and clean energy, and government innovation and era of artificial intelligence. Please visit eit.org for more details. At the Ellison Institute, we believe that an inclusive, collaborative team atmosphere is just as important to our mission as our scientific aims and methods. We strive to build a supportive environment where everyone feels confident taking creative risks toward innovation. We value emotional intelligence and communicating with empathy and respect for others. We foster a team that is curious, has a deep sense of commitment, responsibility, and the resilience needed to achieve excellence. Job Summary: We are establishing a clinical research network and are on a mission to revolutionise clinical research in Africa. Our vision is to build a sustainable, African-led research ecosystem that drives health equity and innovation. By establishing a network of world-class clinical research sites and capabilities, we aim to generate the evidence Africa needs to inform health decisions and policies, while cultivating the next generation of African scientific leaders. Africa has been underrepresented in global clinical research, conducting only 2% of clinical research despite shouldering 25% of the world's disease burden. While there have been significant investments in disease-specific clinical research sites and networks, these approaches have often led to fragmented infrastructure, limited capacity, and reliance on expatriate leadership. Such models have struggled to drive long-term sustainability or meet the broader health needs of African countries and regions beyond narrow therapeutic areas. Consequently, health products and policies in Africa are often informed by data from other settings, which may not fully account for the rich diversity of African populations and local contexts. This lack of locally relevant evidence hinders the development of tailored health solutions that effectively address Africa's unique challenges and priorities. Our clinical research network is on a mission to transform this landscape. By partnering with leading institutions and trial units across the continent, we will establish a network of clinical research sites that serve two critical goals: diversifying global research and empowering Africa to meet the healthcare needs of its rapidly growing population. Our network will be designed to catalyse Africa's self-sufficiency in pharmaceutical and vaccine R&D and manufacturing, ensuring the continent can drive its own health innovation agenda. We will establish digital and clinical infrastructure, while prioritizing deep community engagement to foster trust, relevance and impact. At our sites, we will conduct rigorous, ethical research that puts African populations and priorities at the centre. By generating high-quality local data that reflects the diversity of African contexts, we can accelerate the development and delivery of tailored global health solutions - for Africa, by Africa. Our goal is to build sustainable research capacity that outlasts any single study or funder, empowering African institutions to become global leaders in clinical research and scientific innovation for generations to come. The role: We are seeking an experienced Clinical Trial Protocol Writer to support our clinical research team on a project basis. The successful candidate will be responsible for drafting clear, concise, and compliant clinical trial protocols in accordance with regulatory guidelines and industry best practices. This role requires a strong understanding of clinical research methodologies, protocol development, and regulatory requirements. Key tasks and responsibilities include: Collaborate with principal investigators, medical experts, and cross-functional teams to develop clinical trial protocols. Conduct literature reviews and research to support protocol development, including background information, study objectives, endpoints, and inclusion/exclusion criteria. Write and/or edit protocol documents, including study synopses, study protocols, amendments, and informed consent forms, ensuring clarity, consistency, and scientific accuracy. Incorporate feedback from internal and external stakeholders to refine and finalize protocol drafts in a timely manner. Ensure compliance with regulatory requirements throughout the protocol development process. Conduct quality assurance checks to identify and address any discrepancies, inconsistencies, or potential protocol deviations. Provide support and guidance to research team members on protocol-related issues, including protocol interpretation, protocol amendments, and study conduct. Qualifications Include: Bachelor's degree relevant scientific field (e.g., clinical medicine, biology, pharmacology, public health) required and/or English (with significant subsequent exposure and training in clinical research grant-writing). Master’s or Advanced degree in relevant scientific field considered a strong plus. Significant experience in clinical trial protocol writing, with clinical research coordination a plus. Strong understanding of clinical research methodologies, study design principles, and regulatory requirements. Excellent written and verbal communication skills, with the ability to convey complex scientific concepts in a clear and concise manner. Detail-oriented, organized, and able to manage multiple projects simultaneously while adhering to strict deadlines. Ability to work independently and collaboratively in a fast-paced, remote work environment. We are interested in individuals with experienced protocol writing across a wide range of disease areas, especially Infectious Diseases, Vaccines, Maternal/New born Health, Cardiometabolic Disease, Internal Medicine and Oncology. We are also interested in individuals with experience writing for interventional clinical trials (Ph 2 and Ph 3 in particular) and other types of clinical research studies. We will require candidates on an ongoing basis, for short term contracts as and when required. To be part of this exciting network and mission to address health equity in Africa, please apply online with your CV, availability and supporting information. #LI-PE# Powered by JazzHR
Company:
Ellison Institute Of Technology
Posted:
June 10 on The Resumator
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