[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.

Qualifications

• Relevant experience/qualifications in Life Sciences or related field or administration preferred.
• Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
• Entry to less than 2 years’ experience as inhouse CRA or relevant roles.

Responsibilities

• Support the clinical team’s inhouse activities on assigned projects.
• Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF).
• Support the clinical team in essential document development, collection and management process.
• Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained.
• Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials.
• Assist the CRAs with the preparation of onsite or remote monitoring visits.
• Assist with IRB submission including tracker management during project maintenance and close out phase.
• Assist with site specific Clinical Trial Agreement (CTA) and budget negotiation.
• Prepare and update site Subject Visit Template (SVT)’s in accordance with site budgets.
• Take responsibility of submission and tracking of Investigator payments in CTMS.
• Assist with vendor management updates, tracking and payments as requested by the CRA.
• Contact site staff/Investigators on behalf of the CRA to request information or resolve issues.
• Take responsibility of document archiving as per Novotech SOPs.
• Track and report study SUSARs/CIOMS to the relevant stakeholders.
• Participate in activities of the Clinical Operations department.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry.
• Be aware of and adhere to company processes in areas relevant to an Inhouse Clinical Research Associate.

Benefits

• Flexible working options.
• Paid parental leave for both parents.
• Flexible leave entitlements.
• Wellness programs.
• Ongoing development programs.

Company Description

Novotech is a global full-service clinical Contract Research Organization (CRO). We are committed to fostering an environment that reflects the life-changing work we do.

• Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
• Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
• Offers mentorship opportunities, professional development programs, and a dynamic community.
• Client-centric service model for trusted partnerships and accelerated paths to market.