Inhouse Clinical Research Associate

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

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certificatio