Atlantia Clinical trials is a world class provider of human clinical studies. For over adecade we have delivered clinical results to our many clients around the world,on time and on budget. We strive to offer the highest quality science while maintaining a cost-conscious approach to maximise the value proposition for each of our clients. Our state-of-the-art clinic sites both in Ireland and the USA ensure we can offer multicentre multinational studies of all design types,across a broad and diverse array of health areas and product portfolios. Someof our extensive clinical areas are healthy ageing, gastrointestinal function and disorder, physical activity and sports performance, nutritional investigations, stress and cognitive health and decline, cardiovascular health,metabolic syndrome, bone and joint health, immune function and microbiomedysbiosis of the gut, skin, vagina and oral cavity.
Atlantia Clinical Trials is seeking a maternity leave replacement for 12months starting June 2023 for the position of Research Co-ordinator in our Science Team. This full-time hybrid position is based in Cork and will be offered on a fixed term contract basis.
Early career researchers are encouraged to apply. The Research Co-ordinator is responsible for the development of the Protocol and related documents for ethics submission in Atlantia Clinical Trials Ltd.
- Follow a Quality Control process during document development, and adhere to Atlantia and any other relevant third-party policies, SOPs or guidelines at all times.
- Draft, review and contribute to the development of study-related documents (protocol, PIL-ICFs, ethical/IRB applications, recruitment materials) in line with the contract, and ensure any changes are recorded and relayed back to the sales & finance teams.
- Prepare and submit the documentation for ethics, IRB and regulatory applications, and store it according to Atlantia’s SOPs and regulatory requirements.
- Be the key point of contact between Atlantia and the Sponsor during CSP and CSR development and provide support during study lifecycle to address protocol queries.
- Liaise with the Operations Team to ensure the design is feasible within the proposed timeline and allocated resources.
- Handover the protocol and daily log containing important information gathered throughout protocol development to the Project Manager and Study Team in an interactive presentation to aid in the team’s understanding of the study.
- Provide support to Project Manager and present at Site Initiation Visit.
- Work collaboratively with other departments including Operations, Data Managers and Quality, as needed.
- Work with Statisticians and Clinicians to interpret study results.
- Contribute to the development of Clinical Study Reports ensuring the content is scientifically accurate, evidence-based, grammatically accurate, and referenced using appropriate sources.
- Represent Atlantia at conferences, events, open days etc.
- Where appropriate, contribute to drafting scientific papers for publication.
- Perform other duties as assigned.
- Assumes individual responsibility for own deliverables and deadlines.
- Assumes collective responsibility for successful on-time completion of projects.
Education, Experience, and Skills
- Required: an Honours Master’s Degree in health sciences or nutrition-related field or an Honours Bachelor's Degree in health sciences or nutrition-related field with a minimum of 2+ years relevant experience with scientific writing.
- Required: Excellent written scientific writing skills (e.g., ability to write technical and layman information summaries).
- Required: Proficient IT skills using Microsoft Office 365 and project tracking software (e.g., Teamwork, Microsoft Planner, Microsoft Project).
- Required: Excellent time management and organisational skills.
- Required: Excellent verbal and written communication skills.
- Required: Good knowledge and experience of clinical trials, including the interpretation and implementation of ICH guidelines and ethics submission.
- Desirable: Good knowledge and experience of FDA regulations for clinical trials.
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