The post holder will work within the Royal Marsden NHS Foundation Trust (the Trust) and the Institute of Cancer Research (ICR) Tissue Collection Facility and be responsible, in conjunction with the other Biological Specimen Coordinator(s) for collecting, cataloguing and processing clinical samples (usually tumour and blood specimens) for Translational Research within the Gynaecology Unit.
Main duties of the job
- The post will be responsible for research samples coming through the unit and will ensure all procedures meet with Human Tissue Act (HTA) requirements and Good Clinical Practice UK Regulations for hosted commercial/academic studies as well as all tissue retrieved for central review from all participating centres in the UK and globally for the Trusts sponsored studies running through the Gynaecology unit
- The role will involve supervising and assisting Band 4 Biological Specimen Coordinators with day-to-day tasks.
Job responsibilities
- Working independently daily but as an integral part of a busy research department and being responsible for supervision and collection of patient samples for ongoing studies.
- Be responsible for the day-to-day management of samples from multi-centre studies hosted by the Gynae clinical research unit.
- Act as a point of contact for external trial teams and departments to communicate directly with them regarding data queries, audits and other enquiries relevant to the trials run by the Gynae research unit.
- Assist in the setting up, creating and maintaining efficient administrative systems.
- Assist with the organisation and set up of initiation of meetings.
- Ensure timely and accurate entry of data and relevant information into appropriate database systems.
- The post holder will be required to comment on practices and propose changes to improve the service, and lead on day-to-day service provision.
- Maintain a high level of service, providing holiday/sickness/cover at both the Surrey and London sites as needed.
- Provide training and supervision of Band 4 biological specimen coordinator posts within the team.
- Oversight of Band 4 posts for all tissue collection in relation to hosted and sponsored studies to ensure archival tissue is retrieved from diagnostic centres, logged, tracked and distributed to the relevant sponsor organizations for central review.
Education / Qualifications
- Educated to degree level in a relevant scientific subject or equivalent level of knowledge and experience gained through working in a clinical research, laboratory or tissue banking environment
Experience
- Good Clinical Practice (GCP) training or willingness to complete within an agreed timeframe
- Knowledge of the Human Tissue Act (HTA) and its application within a research environment
- Experience of applying relevant legislation and regulatory requirements, including Good Clinical Practice (GCP) and the Human Tissue Act (HTA)
- Experience of maintaining accurate records, databases and study documentation
- Experience of working independently and prioritising workload to meet deadlines
- Experience of working collaboratively with multidisciplinary teams
- Experience within a clinical trials, translational research or tissue banking environment
- Experience of training, mentoring or supervising staff
- Experience supporting audits and inspections
- Experience of coordinating biological specimen collection across multiple studies or sites
Skills
- Demonstrable technical skills relevant to the collection, processing, storage and tracking of biological specimens
- Knowledge of the Human Tissue Act (HTA), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and their practical application within a research environment
- Ability to plan, organise and prioritise own workload and support the coordination of workloads for other team members to meet competing deadlines
- Ability to maintain accurate specimen records and documentation in line with regulatory and study requirements
- Ability to work independently, using initiative and sound judgement within established policies, procedures and protocols
- Effective verbal and written communication skills with the ability to engage professionally with clinical, scientific, administrative and external stakeholders
- Proficient IT skills, including Microsoft Office applications (Word, Excel, Outlook and PowerPoint) and the use of databases or electronic record systems
- Strong organisational, planning and interpersonal skills, with the ability to manage multiple tasks accurately and effectively
- Ability to identify, investigate and resolve routine issues relating to sample management, documentation and data quality
- Data management, analysis and interpretation skills, including the ability to produce reports and identify trends or discrepancies
- Knowledge of laboratory information management systems, sample tracking systems or research databases
Other
- Professional, reliable and flexible approach to work
- Able to work independently and use initiative
- Commitment to delivering a high‑quality service
- Flexibility to meet service needs, including cross‑site and occasional out‑of‑hours working
- Able to work effectively under pressure and meet deadlines
- Able to work across Trust sites as required
- Commitment to ongoing learning and development
- Strong communication and organisational skills
- Able to work collaboratively as part of a multidisciplinary team
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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