Summary of Post
This position will involve monitoring RCSI sponsored clinical trials for compliance with the International Council on Harmonisation of Good Clinical Practice guidelines (ICH GCP) and applicable regulatory guidelines. In addition, this role will include pharmacovigilance duties on behalf of the RCSI Sponsorship Office.
Specifically, the duties of the post are: Pharmacovigilance responsibilities will include:
• Review of standard operating procedures to support RCSI pharmacovigilance processes
• Collection, processing, and tracking of serious adverse event reports from hospital sites
• Quality Control (QC) checking of collection, processing, and tracking of serious adverse event reports
• Assist the QRAM with safety-related regulatory reporting to competent authority and ethics committee(s)
• Assist the Principal Investigator and the Quality and Regulatory Affairs Manager (QRAM) in the training of clinical site staff on safety reporting requirements and processes
GCP monitoring responsibilities:
Be responsible for the monitoring of RCSI sponsored studies or external studies as assigned to you, to include but not limited to;
• 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;
• Check for the proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials;
• 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.
• Support regulatory inspection activities as required.
• Act as direct line of communication between the site team personnel and the RCSI Sponsorship Office
• Support the site team personnel with clinical research activities (e.g. SOP development, protocol amendments as needed).
• Assist the QRAM in delivering Good Clinical Practice certification training when required;
• Devise a monitoring plan for each sponsored study you are assigned to
• Assist the QRAM in preparing the Monitoring and Auditing section of clinical trial protocols
• Assist in the delivery of site initiation meetings on behalf of RCSI Sponsorship office 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 support to the PI and QRAM in the start-up, enrolment, follow up and closure of clinical trial activities.
• Provide clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
Professional development opportunities and requirements
• Undertake further education as appropriate to keep updated with changes within the field of Clinical Research or your assigned research project.
• Take responsibility for own professional development and skills updating including maintaining a record of training, continuing education and continuing professional development.
• Attend and participate in:
• In service and staff education.
• Sponsor Management meetings.
• Appropriate outside conferences and/or other professional development activities.
Qualifications – (Essential):
• Degree level qualification (or equivalent e.g. nursing qualification) in a clinical or life sciences related subject.
Knowledge & Experience – (Essential):
• Significant recent experience in a clinical research setting.
• Excellent knowledge of the ICH GCP Guidelines.
• Willingness and flexibility to travel between work sites if required.
• Excellent IT skills including Microsoft Office (particularly Word, Excel and PowerPoint) and internet and email systems.
• Good decision making, critical thinking and problem resolution based skills.
• Ability to build strong working relationships and demonstrates good leadership skills.
• Strong organisational skills and the ability to manage and co-ordinate diverse projects.
• Highly effective oral and written communication skills, particularly report writing.
• Effective negotiating, influencing and persuasion skills.
• Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills to compliment the position.
Knowledge & Experience – (Desirable):
• Relevant experience in any of the following areas: clinical trial monitoring, project management, drug safety, or clinical research nursing.
• Knowledge of HPRA clinical trial and safety regulations, ICH GCP Guidelines, global safety regulations and other applicable regulatory guidance documents.
• Previous experience of clinical research document development and contribution to protocol development.
• Experience of standard operating procedure development or organisational policy development.
• Previous experience in the development and maintenance of safety databases.
• Proven leadership and management skills.
Please apply online through the RCSI careers portal via this link: https://bit.ly/3Rqinz3 with your CV and cover letter.
Please find the full Job Spec PDF at this Link.
Informal Enquiries can be directed to Mandy Jackson (firstname.lastname@example.org). Please note we do not accept CVs directly.
RCSI affiliated Hospitals (as applicable)