In-House Clinical Research Associate

Do you enjoy ensuring clinical trials run smoothly while maintaining high data quality and compliance?
Are you someone who likes analyzing clinical data, coordinating with study sites, and solving operational challenges in clinical research?

We are looking for an In-House Clinical Research Associate (IHCRA) to support the execution and quality oversight of clinical studies within our Clinical Affairs team. In this role, you will work closely with Clinical Project Leaders and Clinical Research Associates to support remote monitoring, regulatory submissions, site oversight, and clinical data quality activities.

Centralized monitoring and site oversight

• Perform remote monitoring activities in alignment with the study monitoring plan and risk-based monitoring principles.

• Document monitoring activities and follow up on open items to ensure timely resolution.

• Support preparation for on-site monitoring visits, including review of site performance, previous findings, and outstanding actions.

• Build strong relationships with site personnel to support engagement, enrollment, and protocol adherence.

• Identify site training needs and coordinate with CRAs to address gaps.

• Track site performance indicators and escalate concerns related to quality or timelines.

• Support the management and documentation of protocol deviations.

• Contribute to inspection readiness by ensuring monitoring documentation and site records remain complete and up to date.

Regulatory and ethics submissions

• Prepare and coordinate submissions to Ethics Committees (EC), Institutional Review Boards (IRB), and Competent Authorities.

• Compile and review regulatory submission packages.

• Coordinate responses to regulatory authority queries.

• Support submission of protocol amendments, safety reports, progress reports, and end-of-study notifications.

• Track approvals, renewals, and reporting obligations to maintain site compliance.

Data quality and compliance

• Support set-up and testing of clinical systems, including EDC, eTMF, and CTMS.

• Perform clinical data review to ensure accuracy, completeness, and consistency within EDC systems.

• Identify data trends, anomalies, and potential quality risks using a risk-based approach.

• Support database lock readiness and study close-out activities.

• Assist with data cleaning, dataset review, and verification of data structures in collaboration with statisticians.

• Support reconciliation activities such as safety data, protocol deviations, and external datasets.

• Contribute to audit preparation and follow-up of findings.

• Use study trackers and dashboards to support proactive study management.

Required

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field, or equivalent experience.

• 2–4 years of experience in clinical research, for example as a Clinical Trial Assistant, Study Coordinator, or similar role.

• Experience with regulatory submissions.

• Strong knowledge of Good Clinical Practice (GCP), ISO 14155, and regulatory requirements.

• Understanding of clinical monitoring concepts and the clinical study lifecycle.

• Strong analytical skills and attention to detail.

• Excellent communication, organization, and time management skills.

• Ability to manage multiple priorities in a fast-paced environment.

• Proficiency with Microsoft Office and clinical systems such as eTMF, CTMS, or EDC.

• A collaborative mindset and ability to support cross-functional teams.

Preferred

• Experience with remote monitoring or site management activities.

• Experience in medical device clinical trials or implantable technologies.

• Familiarity with risk-based monitoring methodologies.

• Understanding of data protection regulations such as GDPR.

• We strongly encourage internal candidates to apply. Internal applicants will receive priority consideration during the selection process.