Ref #: 25969

Employment type: Permanent - Full-Time

Location: Lima

Posted: 09-Dec-2020

Description

The Clinical Research Associate III may be regionally based and is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications. The CRA III will support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects. The CRA III will expand his/her responsibilities as directed by the Clinical Research Manager [CRM] or Clinical Project Leader.

REQUIREMENTS:
• In-depth knowledge of local regulations and ICH/GCP guidelines
• Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
• Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
• Ability to independently resolve site or study related issues
• Self motivated; detail oriented; team player; flexible
• Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
• Excellent organizational and time management skills
• Prioritizing monitoring activities, as well as mentoring and assisting other CRAs, to ensure fulfillment of multiple project timelines/objectives [these can be solved by the CRA
• Tracking and assuring subject enrollment numbers are congruent w/expectations. • Adherence to the monitoring plans for visit frequency, monitoring nuances and reporting expectations.
• aspect of the study. Additionally, the CRA oversees or confirms adherence to GCP/ICH practices, ensuring quality of study conduct.

Must have written and oral English skills.