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Inhouse Clinical Research Associate
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**Brief Position 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.
**Reporting to**: As indicated on current organisation chart.
**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.
**Senior In House CRA**
- Entry to less than 2 - 3 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) 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.
- 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 logístical 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.
- 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.
**In addition to core activities as senior IHCRA**:
- May provide in-house support for Regional Lead CRAs on large regional projects.
- Act as a mentor to new team members and to any temporary staff who are employed on an ad hoc basis
- Assist with training for the team and be prepared to offer written feedback on performance as part of the Novotech appraisal process.
- May take on a Systems Super User role such as CTMS as required by the needs of the Clinical Operations department.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
