MSD Clinical Research Associate III - São Paulo Capital 

Portugal, Lisbon 

241381387

Job Description

• The role is accountable for performance and compliance for assigned protocols and sites in a country.

• Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

• Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

• Could perform Quality control visits if delegated by other roles and trained appropriately.

CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Demonstrated ability to mentor/lead.

• Hands on knowledge of Good Documentation Practices.

• Proven Skills in Site Management including independent management of site performance and patient recruitment.

• Demonstrated high level of monitoring skill with independent professional judgment.

• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

• Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.

• Experience with conducting site motivational visit designed to boost site enrollment.

• Capable of managing complex issues, works in a solution-oriented manner.

• Performs root cause analysis and implements preventative and corrective action.

• Capable of mentoring junior CRAs on process/study requirements and is able to perform comonitoring visits where appropriate.

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.

• Able to work highly independently across multiple protocols, sites and therapy areas.

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates commitment to Customer focus.

• Works with high quality and compliance mind-set.

• Positive mindset, growth mindset, capable of working independently and being self-driven.

• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience Requirements:
Required:

• Must have direct experience of site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:
Preferred:

• B.A./B.S. with strong emphasis in science and/or biology

Important details:

• The candidate must be from São Paulo (Capital) or neighbor cities.

• This role is expected to travel (75% of time);

• The candidate is expected to travel on day to day basis to complete the requested activities with clients and Clinical Centers.

Current Contingent Workers apply

Not Applicable1st - Day

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:07/06/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.