Clinical Research Associate

Grc - Attica - Alimosmid

HealthcareClinical Researcher

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HealthcareClinical Researcher

Job Description

We are currently looking for a: Clinical Research Associate (CRA)

Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities

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→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
→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

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.

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

Requirements

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Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
Current driver’s license preferred.

We offer an attractive compensation package, outstanding benefits, and an exciting work environment with varied tasks in an international environment.

What We Offer

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Accountability, Accountability, Adaptability, Adverse Event Reporting System, Audit Reporting, Clinical Data Management, Clinical Documentation, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Collection Methods, Data Documentation, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Informed Consent, Liaison Work, Medical Terminology, Office Management, Primary Research, Protocol Adherence {+ 9 more}