Clinical Research Associate

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, 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.

Responsibilities

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:

o Data generated at site are complete, accurate and unbiased.

o 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.

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.

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.

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.

Behavioural Competency Expectations

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

Demonstrated high level of monitoring skill with independent professional judgement.

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

Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements

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