Clinical Research Project Assistant

7 months ago

Birmingham, United Kingdom The Royal Wolverhampton NHS Trust Full time

Two exciting opportunities have arisen within the Clinical Research Network West Midlands (CRN WM) as follows:
Clinical Research Project Assistant 1 x WTE - Central/South Region includingBirmingham, Dudley, Solihull, Walsall, Worcestershire, Herefordshire, Warwickshire.

Clinical Research Project Assistant 1 x WTE - North Region including Wolverhampton, Staffordshire, Shropshire

The Clinical Research Project Assistant would be working closely with the clinical research teams in our Partner Organisations and with the staff at the CRN WM. The post holder will be responsible for the data management of clinical trial patients and will be required to review patient records for information. This will include the accurate and timely entry of clinical data into various data capture systems and supporting query resolution, along with administrative support for research delivery.

Valid driving licence and use of car for work purposes are essential.

The post holder will need to be flexible in their work as the role requires travelling around the region. We’re looking for applicants who can integrate into different teams, be familiar with working with a variety of systems both paper and databases and has ideally worked previously in a research or data management role within a healthcare setting. Excellent communication and IT skills are essential, as is meticulous attention to detail.

CRN West Midlands is hosted by The Royal Wolverhampton NHS Trust.

The Royal Wolverhampton NHS Trust is one of the largest NHS trusts in the West Midlands providing primary, acute and community services and we are incredibly proud of the diversity of both our staff and the communities we serve. We are building a workforce that can help us to fulfil our values, improve quality of care for patients, and solve the health care problems of tomorrow. We’re passionate about the value that diversity of thinking and lived experience brings in enabling us to become a learning organisation and leader in delivering compassionate care for our patients.

We are delighted that we have been rated as“Good”by CQC. We have achieved numerous awards; The Nursing Times Best Diversity and Inclusion Practice and Best UK Employer of the Year for Nursing Staff in 2020.

The Trust is a supportive working environment committed to creating flexible working arrangements that suit your needs and as such will consider all requests from applicants who wish to work flexibly.

To work according to Good Clinical Practice (GCP) and research governance standards for clinical research studies

To provide an effective quality data management service to any Partner Organisation within the Clinical Research Network West Midlands (CRN WM). To act as a resource and role model for junior staff and the wider multidisciplinary team.

To identify and work within Standard Operating procedures (SOPs) in accordance with individual study site requirements.

To support the set up and conduct of randomised controlled trials and other NIHR Portfolio studies

To create databases for identification, tracking, recording and reporting of the patient pathway, relevant to achieving on time and to target objectives for patient recruitment

To ensure that the clinical study protocols you are working on are adhered to. Assist research staff and clinicians to ensure protocols are accurately followed.

In collaboration with Study Managers ensure that every study which involves patients transferring between Organisations has a defined pathway. This will require liaison with staff in multiple organisations.

To transcribe/export data from medical records (paper or electronic) to case report forms (CRFs) (paper or electronic) as required by the protocol and return these to the study coordinating centre in a timely manner, liaising with Research Nurses, Clinicians and other research staff as necessary to ensure accuracy of completion

To act appropriately to report and record serious adverse events, this includes communication with the Principal Investigator and site team, Sponsor teams, relevant regulatory bodies and local personnel.

To take responsibility for liaising with multiple organisations (e.g. Clinical Trials Units) regarding data queries and for checking and resolving data queries, establishing and maintaining a robust system of documenting these queries

Use the Local Portfolio Management System and other trial specific tools to identify when new data is required; take responsibility for quality control, checking validity and completeness of all recorded data and reports presented to the required timetable and to track patient activities across multiple Partner Organisations

Work with other members of the study team in the provision of a comprehensive study service

To complete eligibility forms for study patients and to ensure that all relevant data has been recorded

To randomise /register patients to studies according to protocol requirements, as required

To assist in ensuring

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