Job summary
We are looking for a highly motivated individual with proven ability in data management/data entry and administration to join our Clinical Support Team within Research & Development.
You will have excellent knowledge of good data management principles, evidence of ability to identify errors in data, data query management and data reporting with a strong focus on quality control and improvement
This is an exciting opportunity for a self-motivated and enthusiastic individual with excellent organisational and communication skills and exceptional attention to detail to join our large multidisciplinary team supporting our Clinical Research staff in all aspects of data management, data entry and administration activities
Looking for a new challenge and to be part of a growing team then this could be the opportunity you are looking for. You will be fully supported with training from our experienced research team.If you are interested and would like to know more about the role, please contact:
Tash Winter - Clinical Administration Manager - 01752 432842 tash.winter@nhs.net
***Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
Main duties of the job
The post holder will work as part of the R&D Clinical Support team delivering data entry/administration for the departments research portfolio of commercial, non-commercial and academic clinical trials supporting the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment manager for this post who will put you in touch with the recruitment team. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job description
Job responsibilities
Research and Governance1. Assist the clinical research team in co-ordinating a portfolio of studies.2. Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.3. Assist with data entry according to study complexity and ensure that data is transcribed accurately whererequired.4. Support internal audit and monitoring5. With support, coordinate the study set up process including:- Assist in completing Expression of interest / study selection documents- Liaise with the study sponsor and research team to gather all relevant study information- Prepare submissions for local research and development approval- Coordinate site initiation meetings- Set up the local site file and any relevant databases and documents for the study6. Take a leading role in on-going study coordination including:- Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements- Maintain effective communication between the study sponsor and the clinical research team- Support local implementation of study amendments- Update quality systems to record study information and enrolled patients details- Coordinate and prepare documents for patient visits- Respond to patients/carers telephone calls (who may at times be distressed) tactfully and professionally- Book trial specific investigations and procedures- Collecting prescriptions or investigation results- Coordinate study monitoring visits- Support the research team with data queries and reporting as required- Consistently demonstrate the ability to work accurately7. Take a leading role in study close out procedures including:- Liaise with the sponsor for final monitoring visit- Preparing study documents for archiving- Liaise with R&D and following archiving procedure8. Support appropriate studies within UHPNT and its partner organisations as appropriate.
For further details please see the attached JD & PS
Job description
Job responsibilities
Research and Governance1. Assist the clinical research team in co-ordinating a portfolio of studies.2. Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.3. Assist with data entry according to study complexity and ensure that data is transcribed accurately whererequired.4. Support internal audit and monitoring5. With support, coordinate the study set up process including:- Assist in completing Expression of interest / study selection documents- Liaise with the study sponsor and research team to gather all relevant study information- Prepare submissions for local research and development approval- Coordinate site initiation meetings- Set up the local site file and any relevant databases and documents for the study6. Take a leading role in on-going study coordination including:- Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements- Maintain effective communication between the study sponsor and the clinical research team- Support local implementation of study amendments- Update quality systems to record study information and enrolled patients details- Coordinate and prepare documents for patient visits- Respond to patients/carers telephone calls (who may at times be distressed) tactfully and professionally- Book trial specific investigations and procedures- Collecting prescriptions or investigation results- Coordinate study monitoring visits- Support the research team with data queries and reporting as required- Consistently demonstrate the ability to work accurately7. Take a leading role in study close out procedures including:- Liaise with the sponsor for final monitoring visit- Preparing study documents for archiving- Liaise with R&D and following archiving procedure8. Support appropriate studies within UHPNT and its partner organisations as appropriate.
For further details please see the attached JD & PS
Person Specification
Qualifications
Essential
- GCSEs including English and Mathematics at grade 4-9 (A-C)
- NVQ L3 in Business and Administration
- Or equivalent demonstrable experience
Desirable
- Good Clinical Practice Training
Knowledge & Experience
Essential
- Excellent organisation skills
- Working proven knowledge of Microsoft office packages (spreadsheets, databases, word processing and e-mail)
- Ability to communicate with staff and patients
Desirable
- Understanding of National Institute for Health Research Clinical Research Network
- Understanding of the clinical research process including Good Clinical Practice
Aptitude & Abilities
Essential
- Enthusiastic, motivated and committed to developing a professional service A flexible approach to work and the needs of the service
- A flexible approach to work and the needs of the service
Person Specification
Qualifications
Essential
- GCSEs including English and Mathematics at grade 4-9 (A-C)
- NVQ L3 in Business and Administration
- Or equivalent demonstrable experience
Desirable
- Good Clinical Practice Training
Knowledge & Experience
Essential
- Excellent organisation skills
- Working proven knowledge of Microsoft office packages (spreadsheets, databases, word processing and e-mail)
- Ability to communicate with staff and patients
Desirable
- Understanding of National Institute for Health Research Clinical Research Network
- Understanding of the clinical research process including Good Clinical Practice
Aptitude & Abilities
Essential
- Enthusiastic, motivated and committed to developing a professional service A flexible approach to work and the needs of the service
- A flexible approach to work and the needs of the service
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.
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).
Additional information
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.
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).
