Clinical Trials Assistant

3 weeks ago


Canterbury, United Kingdom East Kent Hospitals University NHS Foundation Trust Full time

Work closely with research delivery staff to coordinate the workload for those research studies requiring laboratory support. Ensure all relevant laboratory equipment, materials and documents are available and current for all studies. Perform phlebotomy on Clinical Trials patients. Assist research stall to collect biological samples from participants as required.

Process blood and urine samples according to specific Central Laboratory Services Manual and Clinical Trial Protocols. Activities include separation of blood samples to obtain serum using a centrifuge, decanting and storing. Preparation of blood smear films and safe disposal of Diff-safe after completing training under supervision. Prepare translational, pharmacokinetic and pharmacodynamic samples for ambient or frozen storage and shipment, as directed.

Obtain and manage all necessary packaging and materials for shipment of samples. Trained and competent in safe handling of dry ice, in accordance with current guidelines & policies Prepare and arrange samples in order for use by research delivery staff. Responsible for maintaining adequate stock levels and ordering and disposing of supplies as date time and supply levels requires. Retrieve anonymised clinical data to accompany samples when removed from storage, as required.

Arrange couriers for safe and timely transport of all clinical samples as required. Accurately complete and maintain all sample logs and laboratory related documentation ensuring the highest levels of research sample / specimen tracking. Manage and co-ordinate the packaging and shipment of laboratory samples in strict accordance with trial protocols and COSHH regulations. Assist in the preparation and follow up of sponsor monitoring visits and in the resolution of subsequent laboratory related queries.

Liaise with external facilities, organisation and sponsors as required. Attend site initiation visits and onsite training. Attend local Principle Investigator and other local meetings, as required. All laboratory procedures and practices are to be carried out in accordance with the appropriate Standard Operational Procedure and Health & Safety Guidelines.

To maintain laboratory policy for protective equipment to ensure personal safety. Under supervision or after appropriate training, carry out clinical procedures required for clinical trials including but not limited to blood pressure recording, heart and respiratory rate, pulse oximetry, height, weight, measurement of collection of blood and urine samples, and conducting electrocardiograms (ECGs). As directed, assist research participants in completing trial related assessments such as paper questionnaires or using electronic data capture devices. Responsible for cleaning and decontamination of research trials laboratory equipment on a weekly basis.

Maintenance of -80 freezer as required. At all times ensures clear, accurate records are maintained. Ensure that all communication with patients and colleagues is carried out with compassion, dignity and a high level of confidentiality in order to ensure that Trust and study protocols are adhered to. Participate in the objectives as set out in the department, care group and Trust polices.

Assist the research delivery team in administrative duties for clinical trial start up, initiation, maintenance and study closure. Work in an efficient and timely manner and to be adaptable to change. Provide input on the review of procedures or possible service developments. Demonstrate a positive professional attitude to the work of the laboratory and other members of the laboratory and research teams.

Provide in-house training/mentoring for research delivery staff when required. Assist in the preparation and follow up of Sponsor Monitoring Visits Follow Trust, Divisional and Departmental Health & Safety Policies Demonstrate self-directed development in work practice.



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