Clinical Research Associate Ii

**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 site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws;
- Regulations, Protocol, Site Monitoring Plan and associated 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 maintenance and study close-out;
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall 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, regulatory affairs, 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/mentor and sharing best practices as appropriate/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 to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

**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 Trial Assistant, Study Coordinator, Regulatory CTC or similar.
- Required direct site management (monitoring) experience in a bio/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 and patient recruitment;
- Demonstrated high level of monitoring skill with independent professional judgment;
- 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.

**B**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 multiple tasks simultaneously in a changing environment, with support from Line Manager.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitm