Clinical Research Associate - Freelancer (12-20 hours/week)

Clinical Research Associate - Freelancer (12-20 hours/week)

Bulgaria - remote

The Emmes Company, LLC ("Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

We are looking for a freelance Clinical Research Associate who will be responsible for monitoring clinical research on 3 centers across Bulgaria to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs and applicable regulations. Regular t ravel to the research site is required.

Responsibilities

• Under minimal supervision, independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits
• As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit with minimal feedback by the report reviewer
• Facilitates and oversees Action Item resolution post visit
• Helps ensure that clinical sites are conducting the study in compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations
• Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff oversight lead
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead
• Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures
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• Serves as point of contact for study site personnel to answer questions and resolve study-related issues under direction of the project CRA staff oversight lead
• Prepares for and attends project team meetings and provides updates on project status and site-specific performance
• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
• Assists in preparing sites for audits and may provide support and cooperation during audits/inspections (including translation to Auditor if needed)
• May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority
• May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans

Experience

• Bachelor's degree (scientific discipline preferred) or equivalent work experience
• Minimum 2-3 years of relevant monitoring experience (on-site and remote)
• Expertise in clinical research operations, including interpretation and implementation of in-country regulations/ICH guidelines
• Exceptional level of attention to detail
• Ability to work on varying projects and exercise critical thinking with minimal oversight
• Excellent interpersonal and communication skills in English (both oral and written)
• Expertise in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities
• Ability to collaborate with internal and external colleagues and work well in team-oriented setting
• Ability to work remotely with a high degree of independence
• Skilled in Microsoft Office Suite

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