Clinical Research Project Manager

Royal College of Surgeons in Ireland
November 13, 2024
Contact:N/A
Offerd Salary:€10
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Contract Type:Fixed Term
Working Time:Full time
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Post Date : 30-Oct-2024 Close Date : 13-Nov-2024

Job Title: Clinical Research Project Manager

Reporting to: Clinical Trials Manager (CVRI)

Accountable to: Sponsorship Office, RCSI

Location: Mater Private Hospital

Remuneration: Subject to experience

Closing Date: 13th of November 2024

Contract/Duration: 3-year fixed term, 0.6 WTE (3 days per week) with the potential of moving into a full-time role (1 WTE)

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”. 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.

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.

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 that RCSI ranks fifth in the world for “Good Health and Well-being” in the Times Higher Education #SDG #SDG Impact Rankings 2024. 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 Respect, Collaboration, Scholarship and Innovation continue to unite and direct our purpose.

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.

Purpose of Post

The vision for Cardiology at the Mater Private Group includes the growth and development of the academic cardiology department. A fundamental part of this vision is to ensure that excellence in clinic care is supported by and in turn partners with research and education, both nationally and internationally. Research and education can positively impact outcomes for patients, referrals and the recruitment of top talent.

The Project Manager will be responsible for coordinating the effective management of investigator led and industry funded research, as part of the CVRI Dublin. The priority is to support the development of the investigator led research and education.

This role is based at the Cardiovascular Research Institute Dublin (CVRI Dublin) in the Mater Private Hospital Dublin, in collaboration with the RCSI University of Medicine and Health Sciences.

Key Duties & Responsibilities:

Reports to the Clinical Trials Manager and will work together with cardiology consultants, nurse specialists, research fellows, research assistants and trials management. Is accountable to the Manager of CVRI Dublin and will work collaboratively within the CVRI Dublin Team. Is also accountable to RCSI sponsor office (for studies sponsored by RCSI). The role will include financial and operational co-ordination of clinical trial activity, and relationship management across various academic institutions (e.g. RCSI) and industry partners, RCSI Sponsorship Office, relationship & responsibility to delivery oversight on behalf of sponsorship office.

Research Management

Oversee the effective co-ordination of studies at the CVRI Dublin and in collaboration with the RCSI Sponsorship Office. All duties will be carried out in accordance with ICH-GCP guidelines and all applicable laws and regulations for the conduct of clinical research.

Clinical Trial Set Up

Supporting the Clinical Trial Management with:

  • Study contract Management
  • Budget Management
  • Submissions & amendments to Irish Ethics
  • Submissions & amendments to competent authority
  • GDPR
  • Site selection and validation
  • Clinical Trial Management

    Work with Clinical Trial Manager / External CRO / Sponsorship Office on:

  • Recruitment strategy
  • Clinical trial monitoring
  • Close-out visit report review and validation
  • Data management and validation
  • Site Payments
  • Amendments of the protocol and PIL/ICF as necessary
  • Pharmacovigilance
  • Study Committees

  • Convene Steering Committees
  • Study Conduct

  • Be the point of contact for CRO operational and funding queries
  • Escalate issues to Sponsorship Office and communicate with CRO any action required
  • Administer funding and payment to CRO
  • Attend and coordinate project meetings
  • Monitoring for protocol and GCP compliance

  • Check that reported study data are accurate, complete and verifiable from source documents;
  • Check for compliance with approved version of protocol, standard operating procedures, GCP and applicable regulatory requirements;
  • Regularly review the status of the contents of the site file;
  • Issue, investigate and resolve data discrepancies.
  • Monitor and maintain site personnel list, qualification and training records.
  • Ensure that all reportable events are identified, clearly documented and reported per protocol and as per applicable regulations.
  • Ensure any identified non-compliance issues are addressed in a timely manner, clearly communicated, documented and escalated as required through monitoring visits.
  • Act as direct line of communication between CVRI, site team personnel and the RCSI Sponsorship Office
  • Assist in the delivery of site initiation meetings on behalf of RCSI Sponsorship office (for RCSI sponsored studies) prior to study start up in association with the PI and his/her team;
  • Be responsible for writing and distributing time sensitive site visit reports, tracking resolutions of outstanding issues, and ensuring compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives.
  • Provide clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Education and Research Development

  • Support the Head of CVRI Dublin in promoting our reputation to deliver excellent care for all patients treated at the Mater Private Network through the alignment of research and education.
  • Work with MPN Quality Department to ensure the CVRI Dublin meet JCI standards
  • Work with CVRI Dublin Manager to promote Research & Education activity both internally and externally.
  • Support the CVRI Dublin Manager in the dissemination of the work undertaken by CVRI Dublin through education and sharing of research (including publications, webinars, conferences etc.)
  • Qualifications – (Essential):

  • Must be academically qualified to 3rd level (Degree).
  • Qualifications – (Desirable):

  • BSc in clinical or life science related subject or equivalent third level qualification.
  • Qualified to Masters level.
  • Experience – (Essential):

  • A minimum of three years' experience in clinical research / project management.
  • Experience – (Desirable):

  • A good understanding of the current Irish medical, academic and health services research environment.
  • Knowledge of research and data protection regulatory and legislative requirements.
  • Solid knowledge of Good Clinical Practice (GCP) requirements.
  • Monitoring for protocol and GCP compliance.
  • Job Specific Competencies and Knowledge

    Research & Education

  • A broad level of research & education knowledge with the ability to apply this in different settings
  • Planning & Organising

  • Demonstrate evidence of effective planning, organising and time management skills
  • Administrative abilities to include Finance, Marketing, Risk & Quality
  • Ability to be dynamic and adapt to change quickly
  • Carries out risk assessment as required.
  • Teamwork

  • Proven project management ability
  • Excellent people engagement skills
  • Ability to work as part of multi-disciplinary team
  • Self-directed, motivated and an innovative approach to work.
  • Communication & Interpersonal Skills

  • Effective communication skills including the ability to present information in a clear and precise manner
  • Be capable of communicating effectively and courteously with a wide variety of departments and individuals, including hospital consultants, senior nursing staff, executive hospital management and industry / academic partners.
  • Personal Competencies

  • Excellent IT skills (Microsoft Office Packages)
  • Ability to maintain motivation to get things done with attention to detail
  • Excellent interpersonal skills
  • Excellent attention to detail
  • Ability to work on their own initiative
  • Excellent problem-solving techniques and effective decision-making skills.
  • 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 Amy Carswell: [email protected]. Please note we do not accept CVs directly.

    Employee benefits

    At RCSI, we help care for our people so they can focus on our mission to educate, nurture, and discover for the benefit of human health. RCSI make sure you have the resources you need to thrive. We offer a wide range of benefits in areas including time away, finance, community, health, and well-being and insuring your financial future. In addition to our city centre campus and world-class facilities, there are a wide range of excellent benefits available to our employees, including:

  • Onsite gym €10 per month
  • Flexible working arrangements
  • Automatic enrolment to a pension scheme for all employees (Willis Towers Watson, pension documents outlined below)
  • RCSI Investment Guide
  • Pension Scheme Guide
  • Benefits Schedule
  • Life assurance/death in service
  • Long term illness/disability income replacement
  • Free advice on health/motor and home insurance
  • Discounted services, including GP
  • Support for parents and carers
  • Taxsaver commuter tickets
  • BiketoWork
  • Free eye test at the National Optometry centre
  • €12/day for parking for all RSCI staff in the St. Stephens green/RCSI car park
  • RCSI's Learning and Development team facilitate and provide training opportunities for all staff
  • Sports and social club
  • Opportunities to volunteer in the community 26.5 days leave - 20 days annual leave plus 6.5 days Privilege days - In addition to your annual leave entitlements and public holidays, RCSI also grants privilege days to our employees (paid time off during Easter and Christmas periods). We also offer a number of leave options to support the working lives of our employees.
  • Paid maternity leave
  • Paid Paternity leave
  • Parental leave
  • Note: This job description may be subject to change to reflect the evolving requirements of the Department and RCSI. Similar vacancies that arise in the next 6 months may be filled from the pool of applicants that apply for this position. RCSI is proud to be an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their gender, civil status, family status, sexual orientation, religion, age, disability or race. RCSI is committed to embedding equality, diversity and inclusion (EDI) across everything we do. This ensures we can all work and learn in an environment defined by dignity and respect. Eligibility to work in Ireland is a requirement of this role, Proof of eligibility documentation will be required at a later date. Under limited and specific circumstances (research/ specialist roles) RCSI may be in a position to seek a hosting agreement and/or work permits. Employees are required to undertake 6 months service in their current role before applying for other internal opportunities, unless agreed in advance by the SMT representative.

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