In-house Clinical Research Associate Job at Novotech – Apply Now!
Are you looking for an exciting opportunity to advance your career in clinical research? Join Novotech, a global Contract Research Organization (CRO), as an In-house Clinical Research Associate (IHCRA) in India. This role is perfect for candidates with a background in life sciences who want to contribute to groundbreaking clinical trials while ensuring compliance with ICH GCP guidelines. If you have 0–2 years of experience in clinical research and a keen eye for detail, apply today and be part of a team that drives innovation in clinical development.
About Novotech
Novotech is a leading full-service Contract Research Organization (CRO) headquartered in Sydney, Australia, with a strong presence across 34 offices worldwide and a team of over 3,000 professionals. We specialize in clinical trial management across all phases and therapeutic areas, ensuring the highest standards of quality, compliance, and efficiency. With a commitment to scientific excellence and regulatory integrity, Novotech partners with pharmaceutical, biotech, and medical device companies to bring life-changing treatments to market. Join us and be part of a global organization that is shaping the future of clinical research.
Job Description:
Job Posting: Inhouse Clinical Research Associate
Location: India
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.
Minimum Qualifications & Experiences:
- 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 in-house CRA or relevant roles.
Responsibilities:
- Support the clinical team’s in-house 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 processes, 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 the relevant team to update and maintain site milestones, subject tracking, and PISCFs, ensuring accuracy and completeness of the data.
- Create the Investigator Site Files, coordinating 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.
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