Company Background

Ascend Clinical Research (ACR) is a clinical trials Site Management Organisation (SMO) offering innovative, agile, and high-impact solutions in clinical trial delivery, patient recruitment, and professional development of the clinical research workforce. Our organisation specialises in the delivery of multi-therapy trials on investigator site level from set up to close out for Phase 2- 4 trials with quality and excellence at its core, as well as local and international partnerships for clinical research workforce training programmes. We place the patient at the core of our service and actively promote diversity and inclusivity in our patient - centred processes. We are guided by our values of integrity, efficiency, commitment, and safety in practice with our organisational undertakings and stakeholder relations.

Role Overview

• Provide patient study information, patient monitoring, and accurate data collection whilst adhering to relevant legislation, national frameworks and ACR-specific SOPs and policies.
• Enhance the overall delivery of clinical research within ACR by providing clinical research experience and working collaboratively with the research team.

Main duties and responsibilities - Overview

• Undertake clinical research nursing activities relating to clinical trials from the start-up to close-out, adhering to ICH/GCP guidelines.
• Review research protocols, identify, coordinate logistics and processes required to adhere to trial protocol, and communicate with the team
• Attend and participate during trial site selection, initiation visits, and study-related trainings.
• Ensure the commercial success of the site by contributing to the recruitment and retention of patients into trials.
• Screening and randomisation of potential study participants.
• Conducting informed consent discussions and receiving informed consent (if approved by the regulatory and ethics committee and as per protocol).
• Completing study procedures (such as phlebotomy, vital signs, ECG, and as per protocol)
• Reviewing and recording of medical/surgical histories and concomitant procedures/medications.
• Safely administer medication/s as prescribed.
• Scheduling and conducting of trial visits and tracking of enrolled trial participants.
• Communicating with the Sponsor, CRO, clinical research associates / Monitors for trial-related queries and activities
• Drug accountability and reconciliation.
• Processing and packaging specimens, per protocol and IATA guidelines.

Clinical Trial Management (CTIMPs and non-CTIMPs)

• Obtain informed consent from participants for CTIMP and non-CTIMP studies as delegated by the Principal Investigator (PI) and within the parameters of the protocol.
• Support participants considering their participation with the decision-making process, ensuring that their information needs are met sensitively and that they have a full understanding of the study, its requirements, and their rights as participants.
• To ensure all safety reports are completed in line with the protocol reporting policy.
• Facilitate and maintain (written and verbal) communication between the PI, research, clinical, and support services teams in ensuring that the study protocol is correctly implemented, and research governance standards are met and maintained.
• Ensuring that all equipment used in the trial is appropriately calibrated and that supporting documentation is retained.
• Perform all visits, observations, and clinical procedures such as monitoring vital signs, body measurements, height and weight, ECGs, venipuncture, cannulation, drug administration with the participants in accordance with the procedures and schedule of the study protocol.
• Undertake laboratory work as per study protocol, including processing, packaging, storing and transportation of samples.
• Provide ongoing support to patients and volunteers with regard to their trial participation.
• Facilitate a harmonious relationship with patients by building good rapport and establishing a constant line of communication for queries and to raise concerns immediately to clinicians, research, or the leadership team, whichever is appropriate
• Ensure that all clinical trial databases and logs are maintained, including updating patient recruitment data on CRIO, our Clinical Trial Management System (CTMS), per patient visit, and as mandated by protocol and patient needs
• Ensure protocol amendments are incorporated into research practice in a timely manner.
• Work within the scope of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.
• Always adhere to the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations.