Senior Clinical Research Associate

at  PSI CRO

Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Home-based position in Argentina
Only CV’s in English will be considered
We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.

Responsibilities will include:

• Training, mentoring and supervising study level responsibilities for Jr. CRAs
• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Delivering training of investigators, site staff and project teams
• Work with complex studies
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be involved in site identification process
• Contact for clinical investigators, vendors and support services in regard to study progress
• Participate in feasibility research
• Preparation and delivering of presentations at Investigator’s Meetings
• Preparation for and attendance at company’s audits; resolution of audit findings
• Support to Regulatory Affairs in procurement of site regulatory documents
• Maintenance of study-specific automated tracking systems

QUALIFICATIONS

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Full working proficiency in Spanish and English
• Independent on-site monitoring experience in Argentina
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Experience in Oncology or Infectious Diseases is a plus
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
  Additional Information
  If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you.
  Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first

• Training, mentoring and supervising study level responsibilities for Jr. CRAs
• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Delivering training of investigators, site staff and project teams
• Work with complex studies
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be involved in site identification process
• Contact for clinical investigators, vendors and support services in regard to study progress
• Participate in feasibility research
• Preparation and delivering of presentations at Investigator’s Meetings
• Preparation for and attendance at company’s audits; resolution of audit findings
• Support to Regulatory Affairs in procurement of site regulatory documents
• Maintenance of study-specific automated tracking system