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”.
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.
* Accountable to the Manager of CVRI Dublin and will work collaboratively within the CVRI Dublin Team.
* Accountable to RCSI sponsor office (for studies sponsored by RCSI).
* Include financial and operational co-ordination of clinical trial activity, and relationship management across various academic institutions (e.g. RCSI) and industry partners.
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
* 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, and pharmacovigilance.
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, 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.
Qualifications – (Essential):
* Must be academically qualified to 3rd level (Degree).
Experience – (Essential):
* A minimum of three years’ experience in clinical research / project management.
Job Specific Competencies and Knowledge
* A broad level of research & education knowledge with the ability to apply this in different settings.
* Demonstrate evidence of effective planning, organising and time management skills.
* Excellent people engagement skills.
* Ability to work as part of a multi-disciplinary team.
* Excellent communication skills including the ability to present information in a clear and precise manner.
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: amy.carswell@materprivate.ie. Please note we do not accept CVs directly.
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