Unleash your potential & join the innovation

Requirements

• Strong time management, organizational, and communication skills.
• Strong organization and interpersonal skills, ability to communicate effectively internally and externally. Maturity to support junior colleagues in their professional development. Ability to influence others, diplomacy, and negotiation skills.
• Computer skills including proficiency in Microsoft Office suite: Word, Excel, and PowerPoint.
• Able and willing to travel and work remotely at least 50% of the time.
• Have a full understanding of Serious Adverse Event (SAE) reporting, narratives, and follow-up of SAEs. Good knowledge of international standards (ICH-GCP/ISO, FDA, EMEA). Positive and energetic attitude, customer service oriented. Willing to take initiative in a dynamic environment. Ability to work independently and as a team member. Hands-on “Startup mentality” is a prerequisite.

Educational Requirements:

• Master’s or Bachelor’s Degree Required, preferably in a scientific or healthcare discipline. Therapeutic knowledge is a plus.
• A minimum of 5 years clinical trial experience of which at least 3 years as a CRA, preferably within a CRO, medical device, or pharmaceutical company.
• Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian). Additional languages are a plus.

The CRA will be responsible for managing and tracking the progress of clinical studies at Hemex. Functional responsibilities will include:

• Manage assigned study sites and multicenter, multinational 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.
• Literature and clinical database review to assess feasibility and study design. Screen potential investigators to evaluate capabilities for conducting clinical trials.
• Conduct and manage 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 the 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. 
• Manage organization of audits and assure inspection readiness activities for monitoring and site-related activities; ensure implementation of corrective actions (CAPA) within specified timelines. 
• Responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations, and SOPs. 
• Support CTM with the efficient conduct of the trial according to timelines and budget. Provide guidance and regular training to CTA and CRA I.

People Management responsibilities:

• Collaborate with the Clinical Operations team through different stages of a clinical study.
• Manage the Sponsor team and Site Staff throughout the assignment.

• Collaborate with 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.

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to info@hemex.ch

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.