Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a Clinical Research Associate to support the design, planning, coordination, and execution of clinical research studies for in vitro diagnostics. This role involves ensuring compliance with regulatory requirements, validating product performance, and collaborating with cross-functional teams. The position requires a proactive individual with strong organizational and communication skills, who is comfortable working both independently and as part of a team.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Conduct and document clinical studies in accordance with protocols, standard operating procedures, and regulatory requirements.
- Validate product performance claims and provide data for critical regulatory submissions.
- Define the functional and clinical utility of investigational products.
- Collaborate with laboratories or key opinion leaders to gather input on investigational products.
- Adhere to quality system policies and achieve quality objectives through daily actions.
- Perform or coordinate study activities, including site selection, initiation, monitoring, and closeout.
- Maintain communication with study investigators to ensure timely completion of studies and achievement of objectives.
- Support post-launch activities by interfacing with cross-functional staff.
- Review cases with investigators to resolve discrepancies.
- Ensure adherence to FDA regulations, Good Clinical Practices (GCP), IVD directives, and internal policies.
Key Skills and Requirements:
- Degree in science or a relevant field; a background in medical technology is preferred but not mandatory.
- Experience in clinical or laboratory research is advantageous.
- Basic knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
- Strong oral and written communication skills in English.
- Excellent planning, organizational, and interpersonal skills.
- Ability to work independently, make sound decisions, and solve problems effectively.
- Proficiency in Microsoft Word, Excel, PowerPoint, and other relevant tools.
- Medical laboratory experience and familiarity with pathology are a plus.
- Strong therapeutic and protocol knowledge.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with colleagues and clients.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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