- Responsible for site initiation, monitoring and closeout activities and preparation of reports for activities conducted in accordance with SOPs.
- Responsible for training of team at site for start up activities & site initiation.
- Collection of essential documents from sites.
- Checking the Site Master File for completeness and updated status, including updates on Investigator Undertaking and Delegation of Duties log.
- Will perform Source Document Verification (SDV) per Monitoring Plan. Will verify that source documents and other trial records are accurate, complete, kept up-to-date and maintained according to applicable SOPs. Discrepancies identified on SDV should be discussed with the relevant investigator(s) and corrected and documented appropriately.
- Will ensure inclusion / exclusion criteria are being followed and the drug is being dispensed per protocol to eligible subjects.
- Will ensure that investigator has reported all SAEs in accordance with protocol and regulatory requirements
- Will review all the ICFs (100 % subjects) for accuracy and completeness.
- Will ensure that eCRFs are completed from the sites as specified in the protocol and/or Monitoring Plan.
- Will facilitate obtaining resolution to Data queries from the sites / Queries resolved in the eCRF.
- Will ensure that the investigator follows the approved protocol and all approved amendment(s), if any
- Will verify that copies of Status Reports submitted by Sponsor are filed in the Site Master File.
- The CRA will be responsible to resolve the QA findings at the assigned sites, within given timelines
- Project, functional and administrative reporting to Manager, Clinical Operations.
- Interfaces with site monitoring team, site personnel, HR, site in-charge and administration executive.
- Science graduate / Post graduate
- 1-4 years of prior experience in conducting site monitoring
- Deep understanding of ICH GCP and applicable clinical trial regulations and guidelines.
- Effective verbal and written communication skills, multitasking ability, persuasive, ability to work amidst demanding timelines.
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Clinical Research Associate - Schaumburg, United States - Trials Pro
Description
Job Description
Job Description1) Key responsibilities:
2) Work relations:
3) Qualifications:
4) Experience:
5) Skill:
