Inhouse Clinical Research Associate

Novotech Clinical Research (Hong Kong) Limited; Hong Kong; On-site; HKD 300,000 - 540,000; Full time

Job summary

Novotech Clinical Research (Hong Kong) Limited is seeking an Inhouse Clinical Research Associate (IHCRA) to support the clinical team on assigned projects in accordance with ICH GCP, local and global regulatory requirements and SOPs. You will manage TMF documentation, assist audits, and support CTMS data integrity.

The role includes preparing site materials, coordinating investigator payments, assisting with CTA and budget negotiations, and working closely with Clinical Operations and Legal

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.
• Entry to less than 2 years’ experience as inhouse CRA or relevant roles.

Responsibilities

• Provide in-house support to the clinical team according to project requirements and SOPs.
• Coordinate and maintain trial documentation (TMF) and assist in audits and final reconciliation.
• Manage the Clinical Trial Management System (CTMS) to ensure site compliance and data accuracy.
• Assist with site file creation, material logistics, and inventory tracking.
• Support IRB submissions, site budgets, CTAs, and related regulatory paperwork as needed.
• Collaborate with Project Management, Clinical Operations and Legal teams for timely processes and communications.

Skills

Attention to detail

Documentation

Regulatory knowledge

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

Novotech Clinical Research (Hong Kong) Limited View all jobs

Inhouse Clinical Research Associate (IHCRA) 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. Responsibilities

Support the clinical team’s inhouse activities on assigned projects. Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs. 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 and 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. May assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. Prepare and amend the CTA within agreed negotiation parameters and policies.

Work closely with the Project Management, Clinical Operations and Legal teams to facilitate timely execution of CTA. Prepare and update site Subject Visit Template (SVT)’s in accordance with site budgets. Take a responsibility of submission and tracking of Investigator payments in CTMS and any finance system.

Complete study finance reconciliation as requested by the CRA, ensuring subjects activities are updated. Assist with vendor management updates, tracking and payments as requested by the CRA including updating laboratory normal reference ranges. As required also support sourcing supplies, shipment arrangement and customs clearance.

As required, may contact site staff/Investigators on behalf of the CRA to request information or resolve issues. Take responsibility of document archiving as per Novotech SOPs. Where required, track and report study SUSARs/CIOMS to the relevant stakeholders, i.e., Regulatory Authorities, Investigators and Sponsors according to the Safety Management Plan and Clinical Monitoring Plan.

Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Be aware of and adhere to company processes in areas relevant to an Inhouse Clinical Research Associate.

Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role. Minimum Qualifications & Experience:

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. In House CRA

Entry to less than 2 years’ experience as inhouse CRA or relevant roles.