Job details
What will you do:
The In-House Monitor is responsible for document review, indexing, and quality control as well as filing within the Electronic Trial Master File (eTMF). This role involves performing risk analysis and centralized data review, working cross-functionally with the Clinical Operations team to maintain standards of study quality and performance.
Technical Responsibilities:
- Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents
- Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Documents site and Sponsor contact and study interactions in a timely and professional manner. Assists with resolution of investigational site/data queries.Liaises with project team members regarding study site issues.
- Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
- Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments
- In-house monitor assists lead Monitor and Clinical Study Managers in managing investigational sites, tracking study timelines and ensure compliance with trial protocol, study plans and SOPs.
- Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution to/from investigational sites.
- Proficient in the development and review of Informed Consent Form templates.Evaluates metric data to identify process improvements.
What You Need:
Preferred Qualifications:
- Minimum 3-5 years of work experience
- Clinical study and site level documents understanding, TMF reference models (DIA / CDISC)
- Electronic trial master file . Centralized monitoring and Key risk indicators. Experience in medical device industry
Technical Skills:
- Document management and good documentation practice, experience in internal auditing and site auditing is added advantage
- Development of procedures, process metrics and dashboard
- Communication- Excellent written and spoken business communication skills in English. Systems - Microsoft Office, eTMF (Medidata) or Veeva Vault is required, Smartsheet, PowerBI
Education Requirements:
- Education – Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
- Holds valid GCP / ISO 14155 certification or a post graduate degree in clinical research and has good understanding of medical and clinical research terminology (neurovascular preferred)
