Senior Clinical Research Associate

Psi CRO; São Paulo; Vor Ort; BRL 180.000 - 290.000; Vollzeit

Zusammenfassung

Psi CRO is seeking an experienced CRA to train and coordinate junior CRAs on site. You will mentor, lead monitoring visits and deliver training to investigators and site staff, enabling high-quality data and patient safety.

The role involves complex studies and travel as required to support study progress. The ideal candidate has a Life Sciences degree, strong Spanish and English, and at least 3 years of on-site monitoring experience in Mexico, with exposure to Phase II/III studies and MS Office

Qualifikationen

• College/University degree in Life Sciences or equivalent mix of education and experience.
• Full working proficiency in Spanish and English.
• At least 3 years of independent on-site monitoring experience in Mexico.
• Experience in Phase II and/or III monitoring visits.

Aufgaben

• Training, mentoring and supervising Jr. CRAs on site.
• Preparation, conduct, and reporting of monitoring visits (initiation, routine, closeout).
• Delivering training to investigators, site staff and project teams.
• Perform CRF review, source data verification and query resolution.
• Be responsible for site communication and management; travel as needed.
• Support Regulatory Affairs with site regulatory documents and audits.

Kenntnisse

Spanish (fluency)

English (fluency)

Team collaboration

Communication skills

Mentoring/training

Ausbildung

Life Sciences degree

Tools

MS Office

Jobbeschreibung

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 2,700 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

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
• At least 3 years of independent on-site monitoring experience in Mexico
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Experience inOncology orInfectious 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.

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply