Clinical Research Assistant / Coordinator

Post Date : 21-Mar-2024 Close Date : 04-Apr-2024

Job Title: Appointable at either Clinical Research Assistant or Clinical Research Coordinator level, dependent on experience

Department: Department of Paediatrics, RCSI

Reporting to: Prof Paul McNally, Department of Paediatrics, RCSI

Location: Employed by RCSI and seconded to Children's Health Ireland

Contract/Duration: Specified purpose contract for up to 2 years

Remuneration: Level 2, point 1 – Level 2 point 4 of the IUA salary scale (dependent on experience)

Proposed Start Date: 6 May 2024

Royal College of Surgeons Ireland (RCSI):

RCSI is a community of academic, research, clinical and professional staff working collaboratively to lead the world to better health. Here, you will thrive in an innovative and inclusive atmosphere and your personal development and wellbeing will be supported. We invite you to join us to help deliver on our exciting mission “To educate, nurture and discover for the benefit of human health”.

For each of the last six years, RCSI has been positioned in the Top 300 of universities worldwide in the Times Higher World University rankings. We are proud to announce that RCSI has ranked first in the world for “Good Health and Well-being” in the Times Higher Education #SDG Impact Rankings 2023. This reflects our commitment to supporting people of all ages to live healthy lives and our work to promote the concepts of well-being and positive health. Our values of R espect, C ollaboration, S cholarship and I nnovation continue to unite and direct our purpose.

Innovating for a Healthier Future 2023-2027 is RCSI's new five-year strategic plan. Through it, RCSI will enhance human health by meeting the health workforce needs of society, creating the insights and inventions that drive health improvements, and working in partnership with patients and the public in support of better health and well-being for all. The strategy unites the RCSI community in supporting the UN Sustainable Development Goals – with a particular focus on Goal 3, which targets good health and well-being. More details about RCSI can be found at www. rcsi.ie; in particular, I would point potential applicants towards the 2023 Institutional Review document, which gives a comprehensive overview of RCSI's governance and breadth of scope – Access here

We seek candidates whose experience to date has prepared them to contribute to our commitment to the “Race Equality Action Plan 2021-2024” at RCSI. Our students come from all walks of life and so do we. We hire great people from a wide variety of backgrounds. This makes our university stronger and ensures we hire the best talent.

About Our Research

RCSI recognises that excellence in research is critical to the quality of its educational activities, its credibility, and, overall, to its mission to enhance human health. RCSI's research strategy aims to build upon its strength in translational biomedical and clinical research to deliver transformational, high impact changes in health care. Targeting both Irish national and EU funding, along with increased collaboration with industry, is a major part of the RCSI research strategy. Forging increased collaboration between RCSI PIs and industry is of critical importance to achieving success in this area. RCSI is also committed to provide its researchers with the supports and developmental opportunities to enable them to continuously grow and support their overall career development.

Summary of Post

The role of a Clinical Research Assistant (CRA)/Clinical Research Coordinator (CRC) is primarily a patient facing role. The CRA/CRC has a key role in coordinating clinical research activities. The CRA/CRC will work directly with the clinical teams at each site under the direction of the principal investigator and project manager(s). Training, supervision and monitoring specific to the study will be provided prior to and during the studies.

The CRA/CRC will report to the local PI for site specific clinical research matters, to the project manager for study related matters, and to the CHI Research Operations manager for CHI research governance issues.

Candidates appointed at Clinical Research Assistant level will have the opportunity to transition to Clinical Research Coordinator role, subject to a successful performance review after 12 months.

Specifically, the duties of the post are:

Completing protocol specific training and education

Performing study assessments (subsequent to training) including: Lung clearance index, Spirometry control for CT scans, ECG, Sweat testing, Biological sample collection and processing, Administering questionnaires

Assist in the process of study information dissemination and informed consent/assent.

Ensure the tracking of study activities and milestones in a timely manner.

Cross covering of staff at other sites and act as study back-up to other team members to ensure that study timelines are met, as required.

Support the PI, project managers, CRCs and multi-disciplinary team to coordinate the operational aspects of the set-up, maintenance and close- out of research studies and clinical trials.

Support the PI and CHI Research and Innovation Office (RIO) in the collection of essential study documents during set-up and throughout study conduct.

Assist with the preparation of ethics and regulatory applications for clinical trials and research studies, working closely with the PI and Quality & Regulatory Affairs Manager (QRAM).

Support the PI and RIO team in the submission of documents required for local hospital approval.

Coordinate study initiation meetings, monitoring visits, and other Sponsor meetings at each CHI site.

Create and maintain study files and other required documentation, as required.

Manage the processing, storage and shipment of biological samples.

Manage patient reimbursements in conjunction with the clinical research coordinators.

Work closely with the RIO team to support invoicing and financial management.

Support the team to ensure safety reporting is completed according to study timelines.

Work closely with the QRAM to ensure the implementation of Quality Management System (QMS) policies, Standard Operating Procedures (SOPs) and other QMS documents

Assist in the development and implementation of CHI SOPs, training and project management plans.

Contribute towards the development and review of study specific Work Instructions and associated documents, as required.

Support the Clinical Teams to ensure compliance with ICH Good Clinical Practice (GCP) for study related activities.

Support study team with sponsor audits, regulatory inspections and internal audits working closely with the PI and QRAM.

Support the team in preparing for study closure and archiving.

Complete all assigned training and facilitate ongoing personal development and learning.

Mentor and facilitate the development of other team members, as required.

Represent the Research teams and RIO at events, meetings and networking opportunities, as required.

Assist in the preparation of materials for internal and external communications.

Adhere to the RIO and all relevant hospital or institution policies, SOPs or guidelines at all times.

All duties will be carried out in accordance with ICH-GCP guidelines and all applicable laws and regulations for the conduct of clinical research.

Qualifications – (Essential):

BSc or equivalent third level qualification

Knowledge & Experience – ( Essential):

Health research experience

Ability to lead and communicate effectively and in a professional manner

Excellent interpersonal skills

An Individual with initiative, capable of problem solving and working independently

Team player with the ability to motivate colleagues and promote a positive learning environment

Knowledge of medical/scientific terminology

Readiness and ability to learn new skills as required by the position

Excellent attention to detail

Solid knowledge of Good Clinical Practice (GCP) requirements

Knowledge of the governance and legislative requirements relating to the conduct of clinical research in Ireland

Knowledge of electronic data capture systems and the data management process in clinical studies

Previous laboratory experience with the ability to follow SOPs

A full clean driving license and access to own transport

Knowledge & Experience – ( Essential):

Previous experience in a Clinical Research Associate or Coordinator role and working in a clinical environment

Monitoring and audit experience

Previous laboratory experience in particular, experience in biological sample processing

We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application — we'd love to hear from you.

Application Process

Please apply online through the RCSI careers portal on the closing date with your CV and cover letter.

Informal Enquiries can be directed to Rachel Cregan at [email protected]. Please note we do not accept CVs directly.

Employee Benefits

RCSI make sure you have the resources you need to thrive by offering a wide range of benefits in areas including time away, finance, community, health, and well-being and insuring your financial future. Below are some additional benefits available to you as an RCSI employee:

Minimum of 20 days annual leave, plus an additional 6.5 Privilege days

Flexible/hybrid working options for colleagues across many roles

Additional leave options incl. paid maternity leave, paternity/parental leave, study leave

7% Employer pension contribution

Onsite gym €10 per/mth incl. classes and PT sessions

Childcare support 20% discount at Giraffe

Free eye test and annual flu vaccination

TaxSaver commuter tickets and Bike to Work schemes

A site sustainability team focusing on the environmental initiatives; Green Campus Initiative '

Competitively priced café and restaurant

Equality, Diversity & Inclusion forums, and network groups

Employee assistance programme with Spectrum Life

Learning and Development training programmes incl. LinkedIn Learning for career progression

Discounted services incl. GP visits, 10% off dental, staff parking, mobile tariffs, Group Scheme discount on numerous brands

Sports and social club incl. yoga, Pilates, fitness classes, Zumba, running club, social evenings, Summer BBQ

Ticket Draws for events including; Rugby, Taste of Dublin, Dublin Horse Show, theatre, music & comedy events