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Clinical Trials Assistant
2 weeks ago
To carry out delegated tasks in contributing to the local day-to-day running of the INGR1D2 study.
- To regularly work without direct supervision, reporting back to the site Principal Investigator, ensuring that they maintain full oversight of the trial at site.
- To fully understand the trial protocol, inclusion and exclusion criteria for the enrolment of patients and to work in line with the trial protocol at all times.
- To be aware of and to work in line with local protocols and procedures including but not limited to information governance procedures, infection control procedures.
- To adhere to ICH Good Clinical Practice (GCP) requirements and to undertake regular GCP updates in line with protocol and R&D requirements.
- To have a full understanding of ‘informed consent’ in research, delivering unbiased information to patients.
- To be aware of and work to ensure adherence to NMC Code of Practice.
- To work as a member of a mutli-disciplinary team in a busy, dynamic environment including working in postnatal /antenatal ward, women’s health clinic.
- To be aware of limitations and knowing when to escalate patient queries to an NMC registered professional.
- The post holder will be responsible for working under the supervision of registered clinicians and will report to research midwives and to the Head of R&D.
- To assist with the acquisition and distribution of relevant trial documentation.
- To be responsible for forwarding trial data in a timely manner to the trial coordinating Centre.
- Liaise with clinical trial personnel outside the hospital as necessary.
- To establish “trial site files” for each trial in accordance with ICH good clinical practice (GCP) and Research Governance.
- Collection of patient data from medical notes and completion of case record forms (CRFs) and liaise with Clinical Trial Officers, Research Midwives and Clinicians to ensure correct data collection.
- To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the protocol.
- To assist in ensuring that protocol required tests/procedures are done according to the schedule in the specific protocol.
- Ensure all study documentation is accurate and localised with the correct version numbers.
- To ensure safe filing and storage of study documentation and samples in accordance with ICH GCP and Research Governance.
- To arrange collection of blood samples required as part of the clinical trial and ensure safe and appropriate storage of specimens in conjunction with local nursing teams/phlebotomy/laboratory staff.
You will work within the Research & Development Team, specifically within the Reproductive Health Team within the Women's Health Clinic.
You will work on the INGR1D2 Study specifically.
- To carry out delegated tasks in contributing to the local day-to-day running of the INGR1D2 study.
- To regularly work without direct supervision, reporting back to the site Principal Investigator, ensuring that they maintain full oversight of the trial at site.
- To fully understand the trial protocol, inclusion and exclusion criteria for the enrolment of patients and to work in line with the trial protocol at all times.
