Clinical Research Associate

Requisition ID:  32807  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

 

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

We are seeking a dedicated Clinical Research Associate (CRA) to manage clinical trial sites, ensuring strict adherence to regulatory guidelines, Clinical Investigation Plans, and broader clinical objectives. In this role, you'll be responsible for reviewing and analyzing clinical data, playing a key part in the success of trial outcomes. Ideal candidates will have a strong commitment to maintaining professional expertise through continual engagement with clinical literature. If you are a detail-oriented professional with a passion for advancing clinical research and ensuring compliance at every level, this is the opportunity for you!

 

ESSENTIAL DUTIES

• Conduct site feasibility, initiation, routine monitoring, and study closeout visits.
• Monitor, track, and manage all study related tasks at study sites ensuring compliance with GCP, ICH, applicable regulations and company SOPs.
• Collect, review, track, and ensure appropriate completion of site-specific study/essential documents.  Performs ongoing reconciliation of the Trial Master File (TMF) content to site files.
• Primary contact for study site personnel.
• Provide training to site personnel.
• Track and report progress of study sites.
• Responsible for quality data from study sites.  Ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates.  Ensures timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
• Participate in team meetings. 
• May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team.
• Coordinate, assemble, and ship study related supplies as needed.
• Assist with creation and review of study tools/documents .
• Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc. 

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

Minimum 2 years experience.

 

Skills

• Self-directed with ability to work independently.
• Has a broad understanding of applicable related regulations and ICH GCP requirements.
• Positive and a proactive approach to identification and definition of problems, and with the development and implementation of solutions.
• High level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions.
• Attention to detail and the ability to prioritize.  Strong organizational, planning and follow-through skills.
• Ability to work well under pressure and with tight schedules.
• Ability to exercise jud