Ref #: 30343

Employment type: Permanent - Full-Time

Location: Lima - Peru

Posted: 01-Jul-2021

Description

The Clinical Research Associate II 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 II 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 II 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.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.