Site Inhouse Clinical Research Associate II (EMEA)

Site In-House Clinical Research Associate II (EMEA)
Role Summary
The Site In-House Clinical Research Associate II participates in the planning and execution of clinical studies at
assigned study sites. This role supports timely site activation, protocol compliance, and regulatory adherence during
study startup, execution, and closeout, working in close cooperation with the assigned Site Management team.
Key Responsibilities
Supports regulatory and clinical protocol compliance for all assigned clinical projects at assigned study sites.
Coordinates, in partnership with field and in-house personnel, the startup, maintenance, and closeout of assigned
clinical study sites; acts as primary site contact.
Reviews informed consent documents to ensure all required elements are included.
Reviews and analyzes study data and regulatory documents for accuracy and completeness; supports data query
resolution.
Supports follow-up and resolution of findings from monitoring visits and audits.
Serves as a liaison between clinical study management, site management, and site personnel on protocol-related
issues; escalates as appropriate.
Applies general clinical research processes and regulatory knowledge to process improvement activities.
Supports training of internal and external clinical professionals to ensure compliance with established protocols
and processes.
Updates and maintains internal clinical trial information and document management systems.
Collects and maintains regional and site-specific communication to facilitate study activation and execution.
Mentors less experienced clinical team members; may act as study champion for assigned projects.
May contribute to global or regional process improvements.
Required Qualifications
Bachelor's degree, preferably in natural science, pre-medicine, nursing, or bioengineering; minimum 5 years of
clinical research experience, or an equivalent combination of education and experience.
Strong written and verbal communication, interpersonal, presentation, analytical, and organizational skills.
Ability to interpret basic clinical data and meet deadlines while communicating effectively with all levels of staff.
Proficiency in Microsoft Office Suite and relevant clinical applications.
Ability to work with limited supervision.
Up to approximately 50% travel may be required.
Preferred Qualifications
Strong familiarity with clinical trials research processes; previous research experience in a clinical or corporate
setting.
Certification as a Research Professional by SoCRA or ACRP.