Location: Remote/Oxford Science Park, Permanent, Full-time
Scancell is an AIM listed biotech company developing novel immunotherapies for the treatment of cancer and infectious disease, with facilities on the Oxford Science Park and at Nottingham University.
Scancell is currently conducting a Phase 2 trial of its ImmunoBody® vaccine in melanoma patients, and a Phase 1/2 first-in-human trial of its Moditope® vaccine in patients with advanced solid tumours. The successful candidate will be integrated into a multidisciplinary team involved in the development of the Company’s cancer vaccine platforms.
Scancell currently employs nearly 60 staff, with research scientists located in Nottingham and managerial, translational research, development and administrative staff in Oxford. Scientists working in the Company’s laboratory facilities on the Oxford Science Park support the Company’s clinical trial activities, alongside formulation and analytical development activities for its novel products.
Summary of Post
We are looking for a proactive and ambitious (Senior) Clinical Research Associate to join our growing company. The ideal individual will share our passion for Oncology Clinical Development. Working within a multidisciplinary team at the cutting-edge of scientific breakthrough, you will act as the primary point of contact for oncologists across the UK and their study teams. You will also ensure the clinical trial is executed at oncology sites to the highest standards.
Key Roles and Responsibilities
- Perform clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs
- Perform site selection, initiation, conduct (recruitment, quality data collection) and close out
- Collaborate closely with the Study Project Manager to ensure study timelines are adhered to and required quality standards are maintained
- Support start-up and provide local expertise
- Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
- Provide protocol and related study training to assigned sites
- Conduct monitoring (pre-study, initiation, routine monitoring and closeout) visits per monitoring plan and applicable SOPs
- Conduct co-monitoring visits, if required
- Complete monitoring visit reports in accordance with ICH-GCP, Scancell SOPs
- Manage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Establish regular lines of communication with sites and report site progress, issues and proposed action to Clinical Project Manager
- Ensure inspection readiness of the study and sites
- Attend disease indication project-specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilise opportunities. Constantly strive for operating excellence, question status-quo and promote innovation
Education and qualifications
- Educated to degree level (life or medical science discipline)
- A minimum of 3 years’ experience in the field of clinical research
- Experience in early phase clinical trial preferred
- Previous experience as a clinical research associate/study monitor essential
- Therapeutic experience in oncology and immunotherapy preferred
- Excellent team-working skills with the ability to interact and communicate effectively (both verbally and in writing) with professionals in a multi-disciplinary team
- Thorough knowledge of clinical research concepts regarding drug development phases, clinical research and data management methods
- Ability to work autonomously within stipulated timeframes or deadlines
- Good problem-solving, organisational and leadership skills
- Excellent attention to detail at all times
- Ability to organise and motivate other members of the study team
- Experience in writing clinical study procedures and other clinical documents
- Proficiency in use of MS Office and trial related systems
- Ability to maintain confidentiality and personal integrity in all aspects of work
- Ability to cope under pressure and be flexible with changing priorities or unforeseen circumstances in a challenging environment
- Availability to travel in the UK
The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to changing business needs.
Further details about Scancell may be found at: www.scancell.co.uk.
If you would like to be considered, please send a full C.V. including references, and a detailed covering letter specifying how your particular skills and experience are relevant for this post to: [email protected].
Salary: Competitive salary and comprehensive employee benefits
Closing date: Friday 1st March 2024
Applications from recruitment agencies will not be accepted.