Clinical Research Project Assistant

Job description

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

Qualifications

Essential

• Educated to Diploma Level or equivalent in a healthcare related field
• Valid driving licence and use of car for work purposes

Flexibility

Essential

• Able to pay attention to detail and accurately complete case report forms etc.
• Able to change tasks according to changing priorities.

Experience/ Skills

Essential

• Proficient in Microsoft Office Suite, Excel, Access and PowerPoint.
• Able to assess and interpret clinical/non-clinical information and events in order to determine the appropriate course of action. Organised.
• Preparing paperwork around deadlines of various committees, regulatory agencies and meetings
• Able to work in a team
• Able to implement policies for own role and develop working practices or procedures for own work area
• Able to explain and demonstrate own duties to new and less experienced staff.

Communication

Essential

• Excellent verbal and written communication skills. Able to communicate effectively at all levels.
• Able to provide and receive information orally, in writing or electronically in order to undertake own job and inform work colleagues, patients, carers, external bodies and various Delivery Organisation departments.

Desirable

• Able to create and update study databases etc. Able to use computer software to prepare emails, letters and documents.
• Able to work with minimal supervision both alone and as part of a team.

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

Employer's website

https://www.royalwolverhampton.nhs.uk/ (Opens in a new tab)