Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that has been working to improve the health and well‑being of people around the world since 1909. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
POSITION SUMMARY
Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provide support in the oversight and management of vendors. Conduct a review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
What You’ll Do
Assist in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
Have a good knowledge of the therapeutic area and product.
Obtain a complete understanding of all trial‑related documents and operational procedures with moderate direct supervision.
Audits/Inspections/Quality Assurance (QA)
Support effective and timely audit/inspection responses.
Clinical Trial Design/Performance
Gain exposure/participate in case report form (CRF) development, interactive "X" recognition system (IXRS) set‑up, central laboratory set‑up, and other vendor selection processes and be capable of training others.
Oversee completion of Pre‑Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close‑Out Visits (COVs) to determine protocol and regulatory compliance.
Contribute to the resolution of escalated issues from study centres, regulatory authorities and institutional review board (IRB)/independent ethics committees (IEC) with the support of the supervisor, if needed.
Perform Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and document the visits in the Sponsor Site Visit Report.
Ensure timely execution of the clinical studies, generating quality data that ensure the well‑being of the study subjects and trial integrity with moderate supervision.
With the support from the supervisor, may assist in the creation, review and tracking of study documents.
May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.
Clinical Trial Materials (CTM)
Provide support on the regulatory document review and approval for investigational product (IP) release.
Provide support in clinical product technical complaints and product recall as necessary.
Provide support and information to the CTM staff regarding IP management, as needed.
In‑house Monitoring
May assist with expedited identification, retrieval, and review of study documents particularly those required for site activation/start‑up.
May facilitate investigator site payments, where applicable.
Management/Training Team
Facilitate meetings (e.g. Investigator Meetings, Kick‑off meetings).
May provide support for monitor training and contribute to resolve issues identified.
Collaborate to ensure that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs.
Monitoring
Review and track comments of monitoring reports generated by the vendor (CRO) as part of Sponsor oversight of vendor clinical site monitoring activities.
With the support of the supervisor, verify that study documents (e.g. case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
Track study‑specific tasks and progress of the trial.
Maintain and update clinical trial management system (CTMS) information pertaining to the study.
Oversight of vendor clinical monitoring activities, ensuring adherence to international ethical and scientific quality standards.
Collaborate with data management to resolve queries.
Vendor Management
Assist in the management of vendor performance during conduct of the study with moderate direct supervision.
Assist in evaluation of vendor performance during conduct of the study.
Review/create/tracks trial newsletters, memos, mass correspondence, or other appropriate trial‑related documentation, with moderate supervision.
Facilitate scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.
Additional On‑site Monitoring Responsibilities
Perform monitoring/co‑monitoring activities for site initiation visits, interim site monitoring, and closeout visits in conformance with relevant laws, regulations, guidelines and internal SOPs/policies.
Identify, screen, and qualify investigators through feasibility questionnaires and pre‑study visits.
Reconcile clinical supplies and drug accountability records at study sites.
Verify that study documents are tracked and reviewed for completeness and accuracy to ensure data integrity.
Identify and effectively document site findings with an equal ability to re‑train, place corrective action, and follow‑up as required.
Review, clarify, and obtain data changes via query resolution with site personnel.
Conduct completion of PSVs, SIVs, IMVs, and COVs to determine protocol and regulatory compliance.
Prepare telephone contact reports, confirmation letters, site visit reports, and follow‑up letters to accurately document site status and activities in agreement with the Clinical Monitoring Plan.
Safety
Understand and implement processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitor compliance of these processes.
What You’ll Bring
Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g. independent monitoring, co‑monitoring, accompanied site visits).
Associate’s degree in a life science field required.
Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co‑monitoring).
4 years clinical research experience with 2 years experience as a CRA.
Bachelor’s degree or higher degree in a life science field preferred.
Our Benefits Include
Highly competitive salary.
Group pension scheme – contribution rates are (1.5% / 3% / 5% / 7%) and the company will match.
Private medical insurance for the employee (Irish Life).
Ongoing opportunities for career development in a rapidly expanding work environment.
Succession planning and internal promotions.
Education allowance.
Wellness activities – social activities such as padel and summer events.
Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3.
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