IQVIA AG seeks a Clinical Research Associate 2 for an on-site role in Switzerland. The position focuses on site monitoring, regulatory compliance, and study management to ensure data integrity and protocol adherence.
This position is responsible for overseeing clinical trial sites to guarantee that all study activities and data reporting align with the approved protocol, regulatory standards, and sponsor expectations. The associate acts as a key liaison between the company and research sites, ensuring smooth execution and compliance throughout the trial lifecycle.
Responsibilities
- Conduct various site visits, including selection, initiation, routine monitoring, and close-out, following the agreed scope and legal standards.
- Partner with sites to develop and adjust subject recruitment strategies, aiming to improve enrollment predictability and meet project timelines.
- Provide protocol training to site staff and maintain consistent communication channels with site personnel.
- Assess site operations to verify adherence to the protocol and relevant regulations, ensuring data quality and integrity.
- Track study progress by monitoring regulatory submissions, recruitment rates, Case Report Form (CRF) completion, and the resolution of data queries.
- Ensure the Trial Master File (TMF) and Investigator Site File (ISF) are properly maintained and available for filing in compliance with Good Clinical Practice (GCP).
- Document monitoring activities by preparing visit reports and issuing follow-up letters to address findings.
- Collaborate with internal study team members to support overall project execution.
- Assist in creating site-specific recruitment plans when necessary.
- Handle site financial matters according to the clinical trial agreement, including processing invoices as required by local regulations.
Requirements
- Minimum of one year of experience in on-site clinical monitoring.
- Strong understanding and practical application of clinical research regulations, including GCP and ICH guidelines.
- Solid knowledge of therapeutic areas and protocols, typically gained through company training.
- Proficient written and verbal communication skills in English.
- Strong organizational abilities and effective problem-solving capabilities.
- Competent time management and financial oversight skills.
- Ability to build and sustain productive working relationships with colleagues, managers, and clients.
Nice to have
- A bachelor's degree in a scientific or healthcare field is preferred.
- An equivalent mix of education, training, and professional experience may be considered as an alternative to a formal degree.
About the company
IQVIA AG is a prominent global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare sectors. The organization focuses on creating intelligent connections to speed up the development and commercialization of innovative medical treatments, ultimately aiming to improve patient outcomes and population health worldwide. The company upholds strict integrity standards in its hiring process and maintains a zero-tolerance policy regarding candidate fraud.
- IQVIA is recognized as a leading global provider of clinical research services and healthcare intelligence.
- The company is dedicated to accelerating the development of innovative medical treatments to enhance global patient health.
- IQVIA maintains a strong commitment to integrity and enforces a zero-tolerance policy for candidate fraud during hiring.
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