[Hiring] Inhouse Clinical Research Associate @Novotech Global

Role Description

The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.

• Support the clinical team’s inhouse activities on assigned projects.
• Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including:
  • Tracking of documents
  • Preparation for internal/external audits
  • Conducting routine QC reviews and final reconciliation
• Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
• Manage the Clinical Trial Management System (CTMS), ensuring:
  • Site compliance scores are maintained to a high level
  • Data is entered in accordance with company requirements
  • Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data
• Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study.
• Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
• May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
• May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.

Qualifications

• Relevant experience/qualifications in Life Sciences or related field or administration would be preferable.
• Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
• A minimum of 1 year experience as inhouse CRA or relevant clinical administration roles.

Benefits

• Trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework.
• Access to mentorship opportunities and professional development programs.
• A dynamic community that supports personal growth while shaping the future of healthcare.
• Collaborative culture with empowered teams and ongoing support from senior stakeholders and leadership team.