Clinical Research Associate II
4 semanas atrás
Job Description
Responsibilities include, but are not limited to:
- The role is responsible for performance and compliance for assigned protocols and sites in a country;
- Ensures study conduct compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements;
- Acts as primary site contact and manager throughout all phases of a clinical research study;
- Develops and expands territory for clinical research, finding and nurturing new sites;
- Participates in internal meetings as a Subject Matter Expert for monitoring processes;
- Builds strong site relationships and ensures continuity through all study phases;
- Performs site management/monitoring activities in adherence to guidelines;
- Gains a deep understanding of study protocols and related procedures;
- Manages tasks in collaboration with other roles to achieve Site Ready;
- Participates in site selection and validation activities;
Performs remote and on-site monitoring and oversight activities to ensure:
- Data accuracy and completeness at sites;
- Protection of subjects' well-being and rights;
- Conducts various site visits and records clear reports in a timely manner;
- Reviews and monitors required regulatory documentation;
- Communicates with Investigators and site staff on protocol-related issues;
- Resolves site performance and compliance problems;
- Collaborates with various internal and external stakeholders;
- Manages information in various systems;
- Acts as a Subject Matter Expert and mentor;
- Supports audit activities;
- Contributes to the identification of new potential sites according to country strategy.
Requirements:
- Bachelor's degree required, with emphasis in life sciences or related field;
- Fluency in Portuguese and advanced proficiency in English required;
- Prior experience in clinical research;
- Direct site management experience in a bio/pharma/CRO setting required.
CORE Competency Expectations:
- Understanding of clinical research, GCP/ICH, and country regulations;
- Knowledge of Global and Regional Clinical Research Guidelines;
- Good Documentation Practices;
- Skills in Site Management and patient recruitment;
- High level of monitoring skill with professional judgment;
- IT proficiency and adaptability to new applications;
- Ability to analyze data and problem-solve;
- Capability to manage complex issues and implement actions;
Behavioural Competency Expectations:
- Effective time management, organizational, and interpersonal skills;
- Collaborative mindset for skill development across various areas;
- Accountability and ability to set priorities;
- Ability to work in a multicultural environment;
- Demonstrates commitment to Customer focus;
- Professional demeanor and communication;
Important details:
- Candidates preferably from certain regions in Brazil;
- Remote work supported, with extensive travel required;
- Expected travel for daily activities with clients and Clinical Centers;
- Open to candidates legally permitted to work in Brazil from any nationality.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
75%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
YesHazardous Material(s):
NoJob Posting End Date:
05/23/2024*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.
Requisition ID:
R291421-
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