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About the Role

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 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 including tracker management during project maintenance and close out phase.

Requirements

• 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.

Experience Level

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

Benefits

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing development programs
• NovoLife, our flexible benefits framework

About the Company

• Novotech is a global full-service clinical Contract Research Organization (CRO).
• At Novotech, ambition meets opportunity.
• As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth.
• Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
• Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
• This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
• At Novotech, our employees are at the heart of our success.
• By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
• With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
• Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
• At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.
• This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
• At Novotech you will work alongside empowered teams with a shared commitment to success.
• Strategic vs transactional mindset.
• Ability to gain insights and make proactive decisions quickly.
• Culture that fosters partnership and collaboration, where every voice is heard and valued.
• Ongoing support from senior stakeholders and leadership team.

Equal Opportunity

• 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.
• 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.
• We are a Circle Back Initiative Employer and commit to respond to every application.