Senior Clinical Research Associate- Oncology

2 days ago


England, United Kingdom Novotech Full time

Hybrid and Flex Working Options I Inclusive and Vibrant Culture I Career Growth I Diverse Therapeutic Areas










The Clinical Research Associate (CRAII - SCRA), is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.






We offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.






Graduate in a clinical or life sciences-related field. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. For our current opportunities we require experience of working in the research, pharmaceutical industry or a related field per job level as follows:


CRA II: minimum of 6 months of CRA independent monitoring experience
CRA III: 2+ years of CRA independent monitoring experience
SCRA: Min of 4 years CRA monitoring experience
Experience in oncology will be considered as advantage



CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited and smooth management of clinical trials.
Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
Monitoring of investigational sites as per ICH GCP This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.



We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.



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