[概要]
治験の実施に関わる施設選定～データベースロック/治験終了までのモニタリング業務
[具体的な業務例]
・治験契約締結交渉・初回IRB申請手続き
・施設セットアップ、医療関係者トレーニングの実施
・症例登録促進活動の実施、GCP・SOPに基づくモニタリング
・治験の質的管理、原資料等の直接閲覧/症例報告書のSDV実施
・施設における治験費用の管理
・その他、社内のImprovement activity / Task force teamへの参加
Position Summary:
A Site Manager I in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager I is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager I may contribute to process improvement and training.
Principal Responsibilities:
1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
2. Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
9. Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
10. Ensures accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable
11. Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
12. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
13. Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
14. Reviews investigator site file for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
15. Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
16. Attends regularly scheduled team meetings and trainings.
17. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
18. Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).
19. Prepares trial sites for close out, conduct final close out visit.
20. May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
21. May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
22. Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments.
23. Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
24. Coordinates site level lessons learned activities.
25. May contribute to process improvement and training
Principal Relationships:
Primary Reporting Structure: Reports to Functional Manager (FM).
Primary interfaces: FM, CTAs, TMs, SMs. SIPS, PIPS, GTLs, Study Responsible Physicians (SRPs), Quality and Compliance Manager/Specialist, Local Safety Officer
Other Internal Interfaces: C&Gs, GPLs, TA representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Head/US ED&CP head, ED&CP Business Operations & Quality Leader and others as required
External Interfaces: Investigational Site Staff and others as required
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