Research Associate focusing on molecular biology and cell engineering workflows at Biohub. Collaborating in the Virtual Immune System initiative to advance scientific discovery.
About the role
- Clinical Research Associate conducting site monitoring visits in compliance with regulatory requirements. Collaborating with sites to manage project expectations and ensuring adherence to regulations throughout the study process.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 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
- Collaborate and liaise with study team members for project execution support as appropriate
Requirements
- Experience of independent on-site monitoring
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Life science degree educated or equivalent industry experience
- Flexibility to travel to sites
Benefits
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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