Clinical Trial and Operations Administrator

2 weeks ago

London, United Kingdom ESMS Global Full time

**Job Title**: Clinical Trials & Operations Administrator (Maternity Cover)

**Hours**: 37.5 hours; or part time.

**Responsible to**: Project Manager

**Location**: Office based SE1, hybrid remote working

**Job summary**:

- The job holder will be responsible for management of essential documents and the setup of ESMS clinical trial services and medical information services.

**Duties and Responsibilities**:

- Ensure that the physical and electronic document files used by the operations team to answer clinical trial and medical information enquiries are up to date and complete, that documents are filed accurately and are readily retrievable, and physical clinical trial study file indexes are up to date and complete.
- Ensure superseded client documents are archived or disposed of as requested by the client and specified by ESMS record control procedure.
- Maintain various indexes and lists used by the operations team to identify and retrieve documents until these are superseded by an electronic document management system.
- Ensure clinical trial documents and files, and records of transactions relating to them, are managed in accordance with standards of Good Clinical Practice, and that documents and records relating to medical information services are maintained to a similarly high standard.
- Be the focal point for communications with clients regarding documents received from them or returned to them and ensure records are complete and accurate.
- Activate and test access to clinical trial data via interactive voice and web response services (IVRS/IWRS).
- Be responsible for the setup of the service for new clinical trials from both current and new clients, communicating with the client as necessary to ensure efficient turn around between new trial notification and the service going live.
- Collect and analyse key performance indicators, and prepare a range of reports on performance against specified targets.
- Perform administrative tasks to provide day to day support to the operations team such as answering the general administration telephone enquiries, assisting with provision of hospitality, and taking post to and from the post office.
- During occasional periods of staff shortage or sickness assist the operations team by message taking for incoming enquiries, as instructed by the Operations Manager or Deputy.
- Perform general tasks to assist with the distribution and recording of training activities completed by the operations team.
- Be familiar with and comply with all required procedures and work instructions related to the job role.
- Participate in projects to improve processes and systems for information management.
- Participate in internal audit and other quality improvement processes as appropriate.
- Maintain an individual training file and electronic record of all training activities undertaken and be ready to demonstrate your training record at short notice for quality reviews and audits.
- Attend team meetings whenever possible

**About ESMS Global**:
“ESMS, a spin-out from Guy’s Hospital Poisons Unit, provides a unique service to clinical trials that goes beyond a simple unblinding service of the type that an NHS on-call pharmacist might provide.This service is designed to prevent inappropriate unblinding as in most cases, the A&E doctor is confident to proceed with the patient's treatment without unblinding, thus improving patient retention and reducing the need for higher patient recruitment.Retaining patients on study is also crucial to the success of the grant.

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