Site Monitoring Specialist
2 semanas atrás
We are seeking a Senior Clinical Research Associate to join our team.
As a Senior Clinical Research Associate, you will be responsible for monitoring clinical trials in oncology. The ideal candidate will have at least 1.5 years of on-site monitoring experience and a strong understanding of Good Clinical Practice.
You will work closely with sites to adapt, drive, and track subject recruitment plans in line with project needs. You will also administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
The role requires excellent organizational and time management skills, as well as the ability to prioritize multiple tasks and meet deadlines. You should also have advanced level of English language proficiency.
This is a field-based position that requires travel to site locations.
Job Description- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 1.5 years of year of on-site monitoring experience.
- Advanced level of English language proficiency.
This is a field-based position that offers an opportunity to work with a leading global provider of clinical research services.
This position allows you to use your skills and experience to make a real difference in the lives of patients.
This is a remote-based position.
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