Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Conducting clinical monitoring for assigned protocols and investigational sites with an accent on regulatory compliance, GCP, and data integrity. Focus on managing site visits, auditing source documents, and ensuring adherence to local laws and ICH guidelines.

Location: Germany, Austria, and Switzerland

Company

hirify.global is a consulting firm providing end-to-end regulatory sciences and clinical research solutions to biotech and pharmaceutical organizations.

What you will do

• Perform various types of monitoring, including site initiation, interim, and close-out visits, both in-person and remotely.
• Ensure clinical studies are conducted and documented according to study protocols, SOPs, and Good Clinical Practices (GCP).
• Manage study start-up activities, including site identification, feasibility assessments, and Ethics Committee submissions.
• Review source documents and case report forms for accuracy, completeness, and integrity.
• Coordinate with investigators, site personnel, and cross-functional teams to address study needs and manage investigational supplies.
• Develop study-specific monitoring documentation, such as trackers and clinical monitoring plans.

Requirements

• Experience: Over 5 years of experience as a Clinical Research Associate.
• Location: Must be based in Germany, Austria, or Switzerland.
• Education: Bachelor's degree or an equivalent combination of education and experience.
• Technical Proficiency: Experience with EDC, CTMS, IVRS, and eTMF systems.
• Knowledge: Strong understanding of ICH Guidelines, GCP, and local regulatory requirements for clinical trials.
• Skills: Excellent verbal and written communication and interpersonal skills.

Culture & Benefits

• Support for remote working arrangements.
• Hybrid collaboration opportunities for those living near company offices.
• Inclusive workplace culture committed to diversity, equity, and inclusion.
• Personalized application review process without the use of AI screening tools.