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MSD Clinical Research Associate III São Paulo - Capital Portugal, Lisbon 954655930
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Job Description
The role is accountable for performance and compliance for assigned protocols and sites ina 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 standardsand 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 excellentcommunication 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 avirtual 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, conflictmanagement, problemsolving skills.
Able to work highly independently across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multipletasks simultaneouslyin a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish andmaintain culturallysensitive 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 consistentwith organizationalpolicies and practices.
Experience Requirements:
Required:
Must have direct experience of site management (monitoring) experience in abio/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
*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.
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.
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