Clinical Trials Coordinator

The Clinical Trials Coordinator utilises clinical expertise,experience and knowledge to promote and manage the Pinfold Medical Practiceclinical trials team to secure and deliver clinical research projects andstudies. This includes working in collaboration with the Primary Investigatorto review feasibilities and to drive recruitment into studies.

Key responsibilities and duties:

• Work with the Clinical Research Network and Pharmaceutical Companies to identify potential studies and research projects
• Help with marketing the Pinfold Trials Team in searching for new work
• Work with the Primary Investigator to review feasibilities of clinical studies
• Drive recruitment of potential participants identified through the clinical reporting process and other internal referrals
• Coordinate all aspects of the set-up and day-to-day conduct of clinical trials in accordance with ICH GCP and other relevant regulatory guidelines
• Review and negotiate Clinical trials Agreements and Financial Agreements
• Review of data and files in preparation for and prior to audits or site inspections
• Lead engagement with the CRDC on clinical trials and associated research initiatives, serving as the primary representative and point of contact
• Manage the activities of a small research team
• Being comfortable with face-to-face and telephone communication with patients
• Understanding of active protocols and tracking changes and amendments
• Competency with basic lab procedures and biological sample handling

Pinfold Medical Practice have an opportunity for you to be part of a developing research organisation in Primary Care. We have a long history of research activity and are now part of the Leicestershire, Northampton and Rutland CRDC. Also leading local GP practices in the Charnwood Primary Care Research Collaborative, we are building a research organisation capable of delivering trials at scale. This is your chance to be part of this exciting journey.

We offer:

• NHSpension
• Freeon-site parking
• A supportive,friendly and welcoming team environment.

To contribute to all aspects of the planning, conduct and reporting of all clinical trials for Pinfold Medical Practice.

To work on a daily basis with minimal supervision with Research Administrator, Lead GP Partner and Business Manager

Coordinate all aspects of the set-up and day-to-day conduct of clinical trials in accordance with ICH GCP and other relevant regulatory guidelines

To maintain a high standard of patient care in line with NHS/practice policies and protocols and in accordance with the Research Governance Framework.

To ensure that all data is collected and managed effectively and accurately

To contribute to all aspects of the planning, conduct and reporting of all clinical trials within the research speciality

Knowledge of clinical research including issues on ethics, law, drug development and management in clinical issues

Maintaining overall standard of care for patients at all times

Educational and developmental role

Ability to give advice on the organisation and management of research in progress

Liaison with sponsor companies and multi-disciplinary research teams

Key responsibilities

Work with the Clinical Research Network and Pharmaceutical Companies to identify potential studies and research projects

Lead engagement with the CRDC on clinical trials and associated research initiatives, serving as the primary representative and point of contact

Help with marketing the Pinfold Trials Team in searching for new work

Work with the Primary Investigator to review feasibilities of clinical studies

Drive recruitment of potential participants identified through the clinical reporting process and other internal referrals

Review and negotiate Clinical trials Agreements and Financial Agreements

Review of data and files in preparation for and prior to audits or site inspections

Manage the activities of a small research team

Being comfortable with face to face and telephone communication with patients

Understanding of active protocols and tracking changes and amendments

Competency with basic lab procedures and biological sample handling.

Provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.

Assist the clinicians to report and record any adverse events as dictated by Trust and Departmental protocols.

Assist the clinicians with protocol development and ethical approval.

Co-ordinate and carry out patient visits in accordance with study protocols, including co-ordinating special tests in other departments, collection of data, coding, data entry and patient support

Maintain a high standard of patient care in line with Trust and R&D policies and protocols and in accordance with the Research Governance Framework

Ensure that all data is collected and managed accurately

Ensure that patient safety is paramount in all procedures that take place for trial purposes

Have sufficient computer skills for the handling and management of computerised data

Keep up to date with relevant medical literature, developments in clinical research methodology, monitoring and local regulatory and ethical requirements

Attend research network meetings, attend courses, conferences and study days in order to remain up to date with all relevant aspects of clinical research

Participate in the education and development of staff/students, e.g., coordinate clinical supervision and ensure that all personnel are adequately informed about, and comply with all details of the trials.

Participate in the education and development of student nurses.

Review Studies with PI Lead and submit Expressions of Interest where appropriate

Complete and Submit site identification forms for Commercial Trials

Submit Claims for Study Support Costs

Ensure invoices are raised for research costs payable.

Actively Promote research within the practice.

Main Point of Contact for research within the practice, for staff, study teams and patients.

Maintain Study and Recruitment Logs for the Practice and CRN

Be responsible for the day-to-day management of, patient recruitment to research studies

Ensure Ethical / MHRA approvals are in place before studies open or amendments are put in place.

PERSONNEL

• Maintain good industrial relations.
• Take reasonable care of his/her own safety and that of other persons who may be affected by his/her act or omission.
• Co-operation with the Practice to ensure all members of the team adhere to statutory regulations/policies and codes of practice and departments safety rules.
• Offer innovative ways of working, seeking joint solutions to problems and opportunities to facilitate learning.
• Facilitates a learning environment within the team.
• Maintains a caring environment through the support of colleagues.

CONFIDENTIALITY

• In the course of seeking treatment, patients entrust us with, or allow us to gather, sensitive information in relation to their health and other matters. They do so in confidence and have the right to expect that staff will respect their privacy and act appropriately
• In the performance of the duties outlined in this Job Description, the post-holder may have access to confidential information relating to patients and their carers, practice staff and other healthcare workers. They may also have access to information relating to the Practice as a business organisation. All such information from any source is to be regarded as strictly confidential
• Information relating to patients, carers, colleagues, other healthcare workers or the business of the Practice may only be divulged to authorised persons in accordance with the Practice policies and procedures relating to confidentiality and the protection of personal and sensitive data

HEALTH & SAFETY

The post-holder will assist in promoting and maintaining their own and others health, safety and security as defined in the Practice Health & Safety Policy, to include:

• Using personal security systems within the workplace according to Practice guidelines
• Identifying the risks involved in work activities and undertaking such activities in a way that manages those risks
• Making effective use of training to update knowledge and skills
• Being aware of and discharging responsibilities in the process of preventing and controlling infection by using appropriate infection control procedures, maintaining work areas in a tidy and safe way and free from hazards

To follow the Pinfold Medical Practice Health & Safety code and keep updated.

EQUALITY & DIVERSITY

The post-holder will support the equality, diversity and rights of patients, carers and colleagues, to include:

• Acting in a way that recognises the importance of peoples rights, interpreting them in a way that is consistent with Practice procedures and policies, and current legislation.
• Respecting the privacy, dignity, needs and beliefs of patients, carers and colleagues
• Behaving in a manner which is welcoming to and of the individual, is non-judgmental and respects their circumstances, feelings priorities and rights.

PERSONAL/PROFESSIONAL DEVELOPMENT

The post-holder will participate in any training programme implemented by the Practice as part of this employment, such training to include:

• Participation in an annual individual performance review, including taking responsibility for maintaining a record of own personal and/or professional development.
• Taking responsibility for own development, learning and performance and demonstrating skills and activities to others who are undertaking similar work.

QUALITY

The post-holder will strive to maintain quality within the Practice, and will:

• Alert other team members to issues of quality and risk
• Assess own performance and take accountability for own actions, either directly or under supervision
• Contribute to the effectiveness of the team by reflecting on own and team activities and making suggestions on ways to improve and enhance the teams performance
• Work effectively with individuals in other agencies to meet patients needs
• Effectively manage own time, workload and resources

COMMUNICATION

The post-holder should recognise the importance of effective communication within the team and will strive to:

• Communicate effectively with other team members
• Communicate effectively with patients and carers
• Recognise peoples needs for alternative methods of communication and respond accordingly

Contribution to the Implementation of Services

The post-holder will

• Apply Practice policies, standards and guidance
• Discuss with other members of the team how the policies, standards and guidelines will affect own work
• Participate in audit where appropriate

APPRAISAL SYSTEM

An appraisal system is in operation at the practice and is reviewed annually.

RULES

To abide by the Practice Rules and Regulations detailed in the staff hand book.

Job Description will be reviewed annually at Appraisal.

JOB DESCRIPTION AGREEMENT

The list provided is not exhaustive you may asked to carry out tasks not listed in your job description. The practice reserves the right to makes changes to your job description and contract with reasonable notice.

This job description is intended to provide an outline of the key tasks and responsibilities only. There may be other duties required of the post-holder commensurate with the position. This description will be open to regular review including at annual appraisal and may be amended to take into account development within the Practice. All members of staff should be prepared to take on additional duties or relinquish existing duties in order to maintain the efficient running of the Practice.

• Clinical trials co-ordination experience.
• Knowledge of the clinical trials regulatory framework and all stages of the clinical trials life-cycle from set-up to close-out.
• Evidence of effective communication, presentation and interpersonal skills.
• Proven ability to organise and prioritise workload to meet deadlines.
• Proven ability to work independently as well as part of a team.
• Ability to work accurately and methodically with meticulous attention to detail.
• Experience of managing a small team.
• Proven clinical trials co-ordination experience in a primary care setting.
• Creative approach to problem-solving.

• Science graduate or equivalent with recent ICH GCP training

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.