Senior Clinical Operations Assistant
Description
Reporting directly into the Clinical Project Director, this role is to help facilitate recruitment and research delivery in Ixaka sponsored studies and to assist in the management of the accrual of participants in cell therapy research. The role involves the maintenance of the Ixaka recruitment update sheets, providing direct administrative assistance to the project research team, scheduling and patient planning, creation and maintenance of files and maintenance of databases where appropriate.
The position will be based in Seville (Spain).
Responsibilities
- Support the Clinical operations team in all activities associated with the evaluation, initiation, and management of clinical studies, thereby ensuring compliance with Ixaka’s SOPs, EMA and FDA regulations and ICH GCP guidelines.
- Support in the preparation, maintenance and tracking of project and study-related documents including informed consent forms, study plans, instruction manuals, synopses, study protocols and amendments.
- Keeping track of study progress, maintain inspection readiness (approved/agreed/available) of relevant study documentation, patient recruitment etc. by preparing and maintaining appropriate trackers.
- Support the Supply Chain Department on the preparation for and coordination of all procedures related to the collection, handling and shipment of starting materials and final product (active or placebo) in clinical trials.
- To coordinate patient randomization and to schedule shipment and administration of the final product where appropriate
- Coordinate logistics between clinical site, manufacturing facility and couriers related to manufacturing of product for enrolled patients.
- Preparation, distribution and filing of all essential documentation in the Trial Master File (TMF) by reviewing completeness and correctness of documents as appropriate as per ICH GCP.
- Acting as contact person where appropriate for specific vendors to manage related activities, such as translations of documents, courier activities and management of users for relevant systems e.g., ID-Net users.
- Assist with management of study supplies such as ulcer ruler sets, packaging materials for BM, transfer bags if needed etc to clinical sites and liaising with the CRO.
- Act as the cover contact for project team as needed when the project team are not in the office.
- Create, update, track and maintain study specific trial management files, tools, systems.
- Assist the project team members with other administrative activities as required e.g., invoice tracking, preparation of status reports and organisations of meetings.
- Ensure compliance with SOPs, ICH GCP regulations for clinical conduct in all aspects of daily work.
- Perform various study related functions as required to ensure the accurate, quality, timely and on budget execution of clinical studies.
- Liaise directly to Ixaka cross-functional teams independently as appropriate to ensure the smooth running of the clinical study/project.
- To keep training records maintained and brought to the attention of the CPD if guided training, whether online or face-to-face is needed.
- To ensure, that the patient’s rights, well-being and confidentiality are upheld at all times and that any deviation from this is managed appropriately.
- Provide training to other team members regarding clinical trial processes where required.
- Delegate tasks to junior staff as appropriate to ensure the consistent management of the study/project.
Requirements
- University Degree or equivalent education/degree in life science/healthcare recommended.
- Minimum 2 years’ experience in a senior clinical operations assistant role or equivalent within a CRO or industry
- Minimum 3 years’ experience in industry clinical research organisation
- Possess a thorough working knowledge of GCP regulations, pharmacovigilance and appropriate training and certification.
- Demonstrable problem solving, conflict resolution, judgement.
- Excellent oral presentation, written and communication skills.
- Proven independent decision making, negotiation and organizational skills.
- Ability to work unsupervised and independently and have excellent interpersonal skills, self-motivation, motivate team members whilst retaining a positive attitude.
- Strong administrative and organisational skills
- Ability to manage priorities and ability to multitask.
- Proactive approach to work
- Able to work under pressure.
- Strong IT skills; Microsoft Office (PowerPoint, Excel, Word and Outlook)
- Attention to detail and methodological approach to work.
- Fluent in Spanish (written and verbal)
- Fluent in English (written and verbal)