MSD Clinical Research Associate II São Paulo - Capital 

Portugal, Lisbon 

350278664

Job Description

Responsibilities include, but are not limited to:

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

• Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company 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;

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial;

• Performs clinical study sitemanagement/monitoringactivities in compliance withICH-GCP, SponsorSOPs, Local Laws;

• Regulations, Protocol, Site Monitoring Plan andassociated documents;

• Gains an in-depth understanding of the study protocol and related procedures;

• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready;

• Participates & provides inputs on site selection and validation activities;

Performs remote and on-site monitoring & oversight activities using various tools to ensure:

• Data generated at site are complete, accurate and unbiased;

• Subjects’ right, safety and well-being are protected;

• Conducts site visits including but not limited to validation visits, initiation visits,monitoring visits,close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner;

• Collects, reviews, and monitors required regulatory documentation for study start-up,study maintenanceand study close-out;

• Communicates with Investigators and site staff on issues related to protocolconduct, recruitment,retention, protocol deviations, regulatory documentation, siteaudits/inspections andoverall site performance;

• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed;

• Works in partnership with GCTO country operations, finance, regulatoryaffairs, pharmacovigilance,legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites;

• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines;

• Contributes to CRA team knowledge by acting as process Subject Matter Expert(SME), buddy/mentorand sharing best practices asappropriate/required;

• Supports and/or leads audit/inspection activities as needed;

• Performs co-monitoring visits where appropriate;

• Following the country strategy defined by CRD and/or CRA manager, contributes tothe identificationof new potential sites and works closely with them to develop strongclinical researchcapabilities.

Requeriments:

• B.A./B.S. required with strong emphasis in life sciences, science in general and/or biology.

• Must be fluent in Portuguese and have advanced proficiency in English.

• Required previous experience in clinical research experience.Related CR experience may include Clinical TrialAssistant, Study Coordinator, Regulatory CTC or similar.

• Required direct site management (monitoring) experience in abio/pharma/CRO.

CORE Competency Expectations:

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

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

• Hands on knowledge of Good Documentation Practices;

• Proven Skills in Site Management including management of site performance andpatient 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;

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

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

ehavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict
  management

• Able to work with other experienced research professions to develop skills acrossmultiple protocols, sites and therapy areas.

• High sense of accountability / urgency. Ability to set priorities and handle multipletasks simultaneously in a changing environment, with support from Line Manager.

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

• Demonstrates commitment to Customer focus.

• Positive mindset, growth mindset, capable of working independently and being selfdriven.

• Demonstrates and projects professional demeanor and communication consistentwith organizational policies and practices.

Important details:

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

• This role expects the finalist 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.