Clinical Research Administrator

General and clerical duties · Maintain standards of Good Clinical practice at all times. · Assist with the efficient and timely set up of clinical trials within PCN, ensuring that all approvals are obtained and stored. · Assist in considering feasibility of participating in future studies, through TPP auditing · Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines. · Maintain “Edge” database of patients invited for trial participation. · Assist with preparation for audit and inspections within assigned trials · Assist with maintenance of clinical trial documentation and site files. · Assist with the tracking and raising of invoices and the development of systems and processes to capture this trial income. · Ensure that data is available and up to date for any PCN research meetings. · Assist with the preparation of audit and inspections documents. · Assist with the tracking and raising of invoices and the development of systems and processes to capture this trial income. · Co-ordinate responses from investigators and team members, collate and report. · Assist to ensure that trial document is archived following the archiving guidelines. · Ensure that office/trial related supplies are adequate and assist with the ordering process. · Undertake general administrative tasks as delegated to contribute to the smooth running of the team. · If required attend project related meetings, investigator meetings to convey the relevant information to study teams. 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. Personal/Professional Development - Training and Support The post-holder will participate in any training programme implemented by the PCN 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 • Demonstrating skills and activities to others who are undertaking similar work. Training and development will be provided in the Practice to support the post-holder to be competent and capable to undertake delegated duties • Relevant supervision will be provided, with mentorship support Communication: The post-holder should recognize the importance of effective communication within the team and will strive to: • Communicate effectively with other team members • Communicate effectively with patients and carers • Recognize people’s needs for alternative methods of communication and respond accordingly. Health & Safety: The post-holder will assist in promoting and maintaining their own and others’ health, safety and security as defined in the PCN 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 • Using appropriate infection control procedures, maintaining work areas in a tidy and safe way and free from hazards • Reporting potential risks identified. Equality and Diversity: The post-holder will support the equality, diversity and rights of patients, carers and colleagues, to include: • Acting in a way that recognizes the importance of people’s 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. Quality: The post-holder will strive to maintain quality across the PCN 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 team’s performance • Work effectively with individuals in other agencies to meet patients’ needs • Effectively manage own time, workload and resources. Contribution to the Implementation of Services: The post-holder will: • Apply PCN 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. Organisational Standards: The post-holder must work within and comply to: - · All policies and procedures, for example Health and Safety (Act 1974), Data Protection (Act 1998) · Maintain strict confidentiality of all information gained in the course of employment · Attend training update courses as appropriate to maintain competent standards within their role · Undertake annual performance review with their manager Your manager will discuss the outline of duties described within this job description with you. The job description will be subject to review at the annual individual performance review. Additional responsibilities This is not an exhaustive list of duties, and the post holder may be required to undertake any other duties, as required, to meet the needs of the service. The employer can determine any additional duties that may be required so long as they do not exceed the level of responsibility expected for the grade of the post, these will be discussed prior to undertaking them. In all tasks that you are undertaking you must be competent and confident to undertake them. Please discuss with your manager. The post holder will work within all the required practice policies and procedures including CQC, organisation, Information Governance and local policies This Job Description is not exhaustive and may be subject to amendment from time to time Job description Job responsibilities General and clerical duties · Maintain standards of Good Clinical practice at all times. · Assist with the efficient and timely set up of clinical trials within PCN, ensuring that all approvals are obtained and stored. · Assist in considering feasibility of participating in future studies, through TPP auditing · Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines. · Maintain “Edge” database of patients invited for trial participation. · Assist with preparation for audit and inspections within assigned trials · Assist with maintenance of clinical trial documentation and site files. · Assist with the tracking and raising of invoices and the development of systems and processes to capture this trial income. · Ensure that data is available and up to date for any PCN research meetings. · Assist with the preparation of audit and inspections documents. · Assist with the tracking and raising of invoices and the development of systems and processes to capture this trial income. · Co-ordinate responses from investigators and team members, collate and report. · Assist to ensure that trial document is archived following the archiving guidelines. · Ensure that office/trial related supplies are adequate and assist with the ordering process. · Undertake general administrative tasks as delegated to contribute to the smooth running of the team. · If required attend project related meetings, investigator meetings to convey the relevant information to study teams. 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. Personal/Professional Development - Training and Support The post-holder will participate in any training programme implemented by the PCN 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 • Demonstrating skills and activities to others who are undertaking similar work. Training and development will be provided in the Practice to support the post-holder to be competent and capable to undertake delegated duties • Relevant supervision will be provided, with mentorship support Communication: The post-holder should recognize the importance of effective communication within the team and will strive to: • Communicate effectively with other team members • Communicate effectively with patients and carers • Recognize people’s needs for alternative methods of communication and respond accordingly. Health & Safety: The post-holder will assist in promoting and maintaining their own and others’ health, safety and security as defined in the PCN 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 • Using appropriate infection control procedures, maintaining work areas in a tidy and safe way and free from hazards • Reporting potential risks identified. Equality and Diversity: The post-holder will support the equality, diversity and rights of patients, carers and colleagues, to include: • Acting in a way that recognizes the importance of people’s 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. Quality: The post-holder will strive to maintain quality across the PCN 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 team’s performance • Work effectively with individuals in other agencies to meet patients’ needs • Effectively manage own time, workload and resources. Contribution to the Implementation of Services: The post-holder will: • Apply PCN 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. Organisational Standards: The post-holder must work within and comply to: - · All policies and procedures, for example Health and Safety (Act 1974), Data Protection (Act 1998) · Maintain strict confidentiality of all information gained in the course of employment · Attend training update courses as appropriate to maintain competent standards within their role · Undertake annual performance review with their manager Your manager will discuss the outline of duties described within this job description with you. The job description will be subject to review at the annual individual performance review. Additional responsibilities This is not an exhaustive list of duties, and the post holder may be required to undertake any other duties, as required, to meet the needs of the service. The employer can determine any additional duties that may be required so long as they do not exceed the level of responsibility expected for the grade of the post, these will be discussed prior to undertaking them. In all tasks that you are undertaking you must be competent and confident to undertake them. Please discuss with your manager. The post holder will work within all the required practice policies and procedures including CQC, organisation, Information Governance and local policies This Job Description is not exhaustive and may be subject to amendment from time to time