Sr. CRA (임상경력 최소 3년 이상)
- Support and provide training for CRA
- Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary
- Participate in setting the internal process proactively.
- Basically, conduct site level activities as a CRA which she/he is responsible for implement total site management including monitoring visits and below activities
- Take responsibilities for specific tasks on projects or acts as the main CRA contact on responsible projects.
- Participate in the process of identification and selection of investigators in collaboration with Project Manager
- Keep manger informed about work progress and any issue to avoid non-compliance. Requires some interaction/ supervision by manger or assigned mentor
- Assume ambassadorial role to facilitate communication between sites and Key line functions to increase value proposition to investigators.
- Facilitate preparation and collection of site level documents, especially ensure all document collected prior to study initiation.
- Participate in Investigator and other external or internal meeting as required
- Arrange on-stie visits and logistics (e.g., travel arrangement)
- Perform on-site visits such as initiation, interim monitoring, close-out in accordance with the monitoring plan
- Conduct on-site study specific training (if applicable)
- Monitor patient safety on-site (review for missing SAEs, AEs, Concomitant medications) and address protocol deviations
- Monitor and maintain ICH-GCP compliance
- Management drug supply and return between site and warehouse. Perform monitoring in pharmacy.
- Ensure site activities in line with milestones (i.e., Startup, recruitment, closeout, etc.)
- Manage recruitment implementing appropriate contingency plans at site level in collaboration with Project Manager
- Responsible for IRB process (termination report, closing report, SAE report, protocol deviation report etc.) and other interim, amendment and final study reporting is done
  by CTA. However, All IRB process is ensured by CRA.
- Assure continual GCP, ICH and SOP compliance (Informed consent process, AE and SAE reporting, CIOMS forms, protocol, drug accountability etc.).
- Maintain deviation log and resolve deviations to standard by remedial action and training for site staffs. Respond to site issue alerted form project team,
  data manager (I.e., non-responsive site, protocol deviation concerns, quality issue, etc. items that required face to face interaction)
- Deliver high quality data and perform data query resolution (both at Site and with Data Management)
- Responsible for the completeness and quality of the investigator site files.
- Collect regulatory documentation for site readiness during the site selection visit.
- Update all relevant tracking system on an ongoing basis
- Generate visit/ contact report in accordance with monitoring plan
- Manage the trial master file
- Attend audit/ Regulatory inspection if requested