Clinical Research Project Assistant
- NHS
- Full Time
- Birmingham
- 26530.00 - 29114.00 a year
Job Description
Job summary
An exciting opportunity has arisen within the NIHR West Midlands Regional Research Delivery Network (RRDN) for a Band 4 Clinical Research Project Assistant(CRPA) 1.0 WTE - to cover the West Midlands RDN North region including Wolverhampton, Staffordshire, Shropshire and the Central/South Region including Birmingham, Dudley, Solihull, Walsall, Worcestershire, Herefordshire, Warwickshire.
Contract: Fixed term until the 31st March 2026.
The Clinical Research Project Assistant will work closely with the clinical research teams in our Delivery Organisations and with the staff at the Research Delivery Network (RDN). The post holder will be responsible for the data management of clinical trial participants and will be required to review medical records for information. The role includes accurate and timely entry of clinical data into various data capture systems and supporting query resolution, along with administrative support for research delivery.
A valid driving licence and use of a car for work purposes are essential for this role.
Main duties of the job
The post holder will need to be flexible in their work as the role requires travelling around the West Midland RDN region. We are looking for applicants who can integrate into different teams, be familiar with working with a variety of systems, both paper and electronic. Ideally you will have 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.
About us
NIHR West Midlands Regional Research Delivery Network 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.
Job responsibilities
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 delivery organisations within the Research Delivery Network (RDN). 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 that protocol required tests/procedures are done according to the schedule in the specific study protocol
Liaise with Study Coordinators for specific study protocols and procedures
To ensure that clinical study recruitment records are accurately maintained.
To ensure safe filing and storage of study documentation and samples in accordance with Good Clinical Practice and Research Governance
Maintain sufficient stocks of documentation and equipment required for studies (e.g. CRFs, Questionnaires, Blood Sample Kits)
To arrange couriering of samples and ensure the contained samples are delivered safely and securely to the necessary destination.
To organise and prepare for visits by trial monitors, inspectors and internal auditors
To attend meetings relevant to the nature of the job
For full Duties and Responsibilities please see attached Job Description on the Trust website
Person Specification
119853472
Essential
- 119853471
119853474
Essential
- 119853473
119853476
Essential
- 119853475
119853479
Essential
- 119853478
Desirable
- 119853477
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
The Royal Wolverhampton NHS Trust
Address
Birmingham Research Park
Birmingham
B15 2SQ
