Junior Clinical Research Associate

HEMEX AG is committed to changing the future of healthcare by guiding
the most promising European start-ups through each and every step to bring
innovative pharmaceuticals, medical devices and in vitro diagnostics to
the market. Headquartered close to the thriving Basel global Life Sciences hub,
the goal at HEMEX is to ensure start-ups have access to a wide range of
tailored products, practical solutions and fundraising support. This empowers
the next generation of transformative discoveries to grow into successful and
sustainable businesses, and drive change in both human and animal healthcare.
For more information, visit our website.

Tasks
- Manage assigned study sites and smaller clinical trials, conduct phase I-IV trials according to protocol.
- Ensure that Essential Documents are available for filing in the electronic Trial Master File (eTMF).
- Verify that the Investigator's Site File (ISF) is maintained in accordance with ICH-GCP/ISO 14155 and local regulatory requirements.
- Conduct monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.).
- Conduct site visits (selection visits, initiation visits, monitoring visits, close-out visits) and write reports to ensure compliance with the protocol, ICH-GCP/ISO 14155, global and local regulations, global and local processes to secure data integrity and patient safety.
- Ensure that site personnel is fully trained on all trial-related aspects during Site Initiation Visits (SIV).
- Independently manage training and support requests from clinical trial sites.
- Proactively identify quality issues at sites; resolve issues and escalate as appropriate.
- Support start-up phase of assigned studies by tracking regulatory submissions and approvals.
- Manage and maintain information and documentation by updating all electronic systems (eTMF, eCTMS) to track clinical trial progress, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Support organization of audits and assure inspection readiness activities for monitoring and site-related activities; ensure implementation of corrective actions (CAPA) within specified timelines
- Responsible for delivering data within timelines and required quality standards, responsible for adherence to monitoring procedures according to GCP and ICH, local regulations, and SOPs.
- Support with writing and/or reviewing protocols, eCRFs, study manuals, and other related documents.

**Requirements**:

- Collaborate with the Clinical Operations team through different stages of a clinical study.
- Manage the Sponsor team and Site Staff throughout the assignment.
- Computer skills including proficiency in Microsoft Office suite: Word, Excel, and PowerPoint.
- Strong time management, organizational and communication skills.
- Strong organization and interpersonal skills, ability to communicate effectively internally and externally.
- Able and willing to travel and work remotely at least 50% of the time.
- Have a complete understanding of monitoring procedures, Serious Adverse Event (SAE) reporting, narratives, and follow up of SAEs. Basic knowledge of international standards (ICH-GCP/ISO, FDA, EMEA)
- Positive and energetic attitude, customer service oriented. Willing to take the initiative in a dynamic environment. Ability to work independently and as a team member. Hands-on “Startup mentality” is a prerequisite.
- Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian). Additional languages are a plus.
- Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian).
- Additional languages are a plus.
- Master’s or Bachelor's Degree Required, preferably in a scientific or healthcare

discipline. Therapeutic knowledge is a plus.
- A minimum of 2 years of clinical trial experience, preferably within a CRO, medical device, or pharmaceutical company.Completion of the CRA training program or prior monitoring experience is a plus.

**Benefits**:

- Join a small team of multinational, multidisciplinary, highly motivated experts.
- Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
- Ability to independently manage your role and responsibilities.
- Opportunity to develop yourself and support start-ups developing highly innovative therapies.
- Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.

If you meet the described profile, we look forward to receiving your CV
and supporting documents (English version).