Research Project Manager

Job overview

This new role involves working within the research delivery and the project support team of the Cardiovascular Research Department. The team is responsible for the set-up and delivery of research studies within Cardiology, Vascular and Cardiac Surgery speciality.

The post holder will project manage multiple studies and work closely with the clinical delivery team, project support team and other staff to ensure studies are set up quickly, completed on time, to target, within budget, and in-line with regulatory requirements and good clinical practice.

This is a wide ranging role with many tasks between feasibility, study set-up to data-lock coming under the responsibility of the project manager.  There will also be involvement in study finances.

Main duties of the job

The post holder will be expected to work closely with the senior research nurses and the Cardiovascular Research Manager to report progress of studies and recruitment statuses to senior staff including Principal Investigators and the Cardiovascular Research Operations Director; trouble shoot, and develop and instigate recovery plans if studies are not running according to plan.

You will delegate trial specific tasks to the project team e.g. research governance administrator(s) and/or Administrators and/or delivery personnel to facilitate study delivery. You will train and develop these members of staff to ensure they are able to carry out their study specific tasks, and to monitor their progress and effect remedial solutions when, and if, required.

Detailed job description and main responsibilities

• You will work across all UHL sites as required, will liaise with sponsors, contract research organisations, the Clinical Research Network, and other external organisations such as other Trusts.
• There may be a very occasional need to undertake flexible working arrangements to meet project demands i.e. working some early and late shifts and occasional weekends. There may be the need to attend meetings nationally.
• Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting.

SCOPE

Budget

• You will work with the Research Delivery Team to ensure expenditure is recorded accurately to enable accurate invoicing of sponsors. To ensure expenditure remains within limits and that there is value for money on all expenditure. Follow in-house finance scheduling processes and reporting, and liaise with R&I finance lead to action raising of invoices in a timely manner.

Staff

• To line manage junior staff, ensuring that all aspects of performance, attendance, sickness absence, training and appraisal are addressed in accordance with Trust Policy.

Policy

• Adhere to all Trust and sponsor policies, research governance framework, information governance and data protection act, Good Clinical Practice and the standard operating procedures assigned to each study the post holder works on.

Communications

• Post holder will be a strong and transparent communicator.

KEY WORKING RELATIONSHIPS

• The main working relationships that the post holder will be required to develop include;
• CV Research Manager
• CV Research Operations Director
• Senior Research Nurses
• Chief/Principal Investigators
• Department clinical team
• Study sponsors/contract research organisations
• R&I department
• Clinical trials pharmacists
• Clinical Research Network East Midlands

KEY RESULT AREAS

Key result areas for this post include;

• Timely set-up of studies.
• Delivery of studies to time and target.
• Timely and accurate reporting of the progress of studies and finances.
• Efficient and effective staff training for study related procedures/processes.
• Efficient and effective set-up and maintenance of internal study management system.
• Develop and maintain good working relationships across the department.
• Develop and support staff that the post holder line manages.
• Oversight of efficient and effective set-up and maintenance of site files.
• Keep all training up to date (mandatory and study related) and seek personal development opportunities.
• Ensure that study data is accurate and robust.
• Ensure the project(s) is delivered within allocated budget and ensure departmental invoicing processes are followed within the expected timelines
• Ensure the effective use of trust resources
• Support grant development with obtaining NHS costings from R&I Finance, when required.
• Management of study recruitment which will include the development of recruitment plans and the leadership of recruitment strategies for example community events, leaflet drops etc.
• Adhere to ICH-GCP

GENERAL DUTIES

In addition to the key job responsibilities detailed in this job description all employees at UHL NHS Trust are expected to comply with the general duties detailed below:

Undertake any other duties that may be required form time to time that are consistent with the scope and sphere of influence of the project aims and objectives.

All employees are subject to the requirements of the Health & Safety at Work Act.  The post holder is required to ensure that as an employee, his or her work methods do not endanger other people or themselves.

All employees are subject to the requirements of the Data Protection Act and must maintain strict confidentiality in respect of patient’s and staff’s records.

All employees must comply with the Trust’s equality and diversity policies and must not discriminate against individuals or groups on the basis of their age, disability, gender, marital status, membership or non-membership of a trade union, race religion, domestic circumstances, sexual orientation, ethnic or national origin, social and employment status, HIV status, or people who are undergoing or have undergone gender re-assignment, marriage and civil partnership, pregnancy and maternity or any other grounds which cannot be shown to be justifiable.

This job description is not to be taken as an exhaustive list of duties and it may be reviewed in the light of changed service needs and development.  Any changes will be fully discussed with the post holder.  The post holder will be required to carry out the duties appropriate to the grade and scope of the post.

In order to ensure the Trust’s ability to respond to changes in the needs of the service, after appropriate consultation and discussion with you (including consideration of personal circumstances current skills, abilities and career development) the Trust may make a change to your location, duties and responsibilities that are deemed reasonable in the circumstances.

Your normal place of work will be as discussed at interview and will be confirmed in Section 1 of your contract but you may be required to work in other locations of the Trust. In particular, flexibility is required across the three main Hospital sites (Leicester Royal Infirmary, Leicester General Hospital, Glenfield Hospital).  If your initial location is based at one of these sites, excess travel reimbursement will not apply for a permanent/temporary change to base.