Senior Clinical Research Associate job at Infiuss Health Tanzania 2023;- Infiuss Health is a software platform that accelerates remote clinical trials in Africa. Our platform connects life science research companies to thousands of eligible participants to take part in their studies. We are building a decentralised platform to power remote research/clinical trials in Africa, by connecting researchers directly to patients and participants. Our Mission is to equip researchers with the digital tools they need to carry out remote research studies across the continent.
We are looking for a field-based Senior Clinical Research Associate in Tanzania to monitor our growth. Wondering why we think you’ll love working for Infiuss Health? Here are 5 reasons!
You won’t be bored. You will work in a fast paced environment to deliver the best service to our customers. Autonomy and ownership are keystones to working for Infiuss. We won’t micromanage and let you take full responsibility and ownership for your work. You’ll work with a team to collaborate and come up with great solutions together We’re eager to grow with you. We welcome new ideas and a team spirit. At Infiuss Health, we embrace the remote culture. Every day you get to choose what environment makes you most productive, while having the opportunity to travel throughout Africa to create meaningful partnerships.
Senior Clinical Research Associate (SCRA)
As a Senior CRA, you will participate in the preparation and execution of Phase I-IV clinical trials with a particular focus on monitoring and site management activities to ensure that timelines and deliverables are met at assigned sites. You will build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP, sponsor requirements and INFIUSS SOPs. You will focus on subjects’ rights, safety and well-being and ensure a high quality of data.
Responsibilities include:
- Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
- Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level
- Perform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits
- Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
- Act as the main line of communication between the Sponsor and the site
- Be a point of contact/liaison for in-house support services and vendors
- Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
- Review the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country level
- Collaborate and liaise with study team members for project execution support as appropriate.
- Ensure copies / originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Ensure copies / originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
Qualifications
- Relevant educational background, such as MD, MPharm, RN or College/University degree (B.Sc, M.Sc. or PhD) in Life Sciences or an equivalent combination of education, training and experience
- Deep therapeutic knowledge
- Minimum of 3 years’ site monitoring experience
- Experience with all types of monitoring visits (Feasibility, Selection, Interim Monitoring & Close-Out) in Phases 1, II and III studies
- Excellent knowledge of ICH GCP guidelines.
- Participation in clinical projects as a Lead/Senior Monitor
- Strong expertise in navigating the intricacies of performing clinical research in the African space.
Full working proficiency in English
- Proficiency in all MS Office applications and Google Drive
- Ability to plan, multitask and work in a dynamic team environment
- Excellent oral and written communication skills
- Excellent collaboration and problem-solving skills
- Ability to travel nationally and within Africa (up to 65% depending on project needs)
- Valid driver’s license
- Strong attention to detail
- Proactive self-starter
- Effective time and financial management skills
Work Hours: 8 Experience in Months: 36 Level of Education: Bachelor Degree
Job application procedure
Please submit your application to [email protected] and include a cover letter, CV and three references. In addition, please submit a short written piece demonstrating your knowledge on one of the following topics: Regulatory & Ethical approval processes
Challenges surrounding Informed consent & patient recruitment. Unique challenges surrounding the performance of clinical research in Africa Unique challenges surrounding the conduct of clinical research.