Senior Clinical Trials Coordinator

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Detailed job description and main responsibilities

TEAM SUPPORT

• Responsible for supporting and supervising workload allocation/ monitoring across administrative team members, escalating issues as appropriate to senior managers.
• Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.
• Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning activities.
• Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
• Assist with data collection for divisional metrics reports of key performance indicators.

CLINICAL TRIALS CO-ORDINATION/ DATA MANAGEMENT

The specific responsibilities will depend on the requirements of each team, but may include:

• Act as a key point of contact with the core Research and Development team, study sponsors, clinical research organisations and specific research teams.
• Support feasibility activities for new studies under direction from senior managers and Principal Investigators.
• Manage the set up and initiation of allocated clinical trials within assigned Clinical Research Teams. Provide support for study set up and initiation that has been delegated to Clinical Trials Coordinators, escalating any delays as appropriate.
• Support with negotiations of study set-up costs and income recovery for assigned clinical trials in conjunction with the Research Division's Business Planning and Finance teams with oversight from senior managers.
• Oversee maintenance of investigator site files and essential documentation in accordance with ICH-GCP and Trust Standard Operating Procedures (SOPs) to ensure they are kept inspection ready at all times.
• Oversee and process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, escalating any delays with the core Research and Development office as appropriate.
• To have the appropriate administrative processes in place to ensure, with the Clinical Research Team, that adverse event incidents and forms are completed, reported and followed up to resolution as the study protocol and regulations require.
• Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing up-dated information on patients included in the study.
• Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
• Liaise with internal staff and external collaborators to resolve queries.
• Provide information for senior managers including (but not limited to) case report form completion timeliness, data locks, data backlogs, work allocations and patient recruitment.
• Ensure that data is available and up to date for any meetings related to the trial/ study, producing minutes as required.
• Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Attend disease-specific research team meetings to maintain an overview of team activity.
• Assist with preparation for audit and inspections within assigned teams and implementation of action plans.
• Ensure that all documents are archived in the appropriate way by following the Trust's archiving guidelines.
• Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
• Demonstrates the agreed set of values and accountable for own attitude and behaviour

WORKING PRACTICE

• Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.
• Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
• The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to senior managers as necessary.
• The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas.

PERSONAL AND PEOPLE DEVELOPMENT

• Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework.
• Participate in and deliver Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.

PHYSICAL, MENTAL AND EMOTIONAL EFFORT

• Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
• Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
• Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.

Person specification

Qualifications

Essential criteria

• Degree in a science or health related discipline.
• Relevant experience in scientific and medical research.

Desirable criteria

• Post graduate certificate in clinical research or other relevant post graduate qualification.
• In possession of or working towards an NHS leadership academy qualification

Experience

Essential criteria

• Significant experience in clinical trial administration and clinical trial data management.
• Experience of mentoring junior staff.

Desirable criteria

• Previous experience of working in the NHS or other healthcare system.
• Line management experience.
• Involvement in education and staff development

Skills

Essential criteria

• Ability to prioritise own and others workload and practice effective time management.
• Excellent written communication skills.
• IT literate including good understanding and demonstrated use of the full Microsoft Office suite.
• Accuracy and attention to detail.
• Excellent interpersonal skills.
• Excellent oral communication skills.

Desirable criteria

• Advanced use of spreadsheets.

Knowledge

Essential criteria

• Good understanding of the clinical research delivery processes, related standards, governance and leglislation.

Desirable criteria

• Understanding of medical terminology and cancer.
• Understanding of case report forms.
• Knowledge of patient information systems.

Values

Essential criteria

• Ability to demonstrate the organisational values and behaviours

Other

Essential criteria

• Ability to work to tight and/or unexpected deadlines.
• Flexible with ability to adapt to service requirements
• Conscientious and hardworking.
• Ability to work unsupervised or as part of a team.
• Tactful and diplomatic.

Desirable criteria

• Evidence of achievement under pressure.

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy

All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.

By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.

You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Employer certification / accreditation badges

Documents to download

• Job Description and Person Specification (PDF, 190.8KB)
• The Christie Values and Behaviours (PDF, 919.5KB)
• Strategy Brochure (PDF, 1.0MB)
• Trust Membership - Christie Talent (PDF, 23.0KB)
• Travel to The Christie (PDF, 3.8MB)