In-House Clinical Research Associate

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Assist the Project Manager, traveling CRAs, and Lead CRA in clinical trial activities.

• Ensure that monitoring tasks receive adequate support.

• Track, gather, and evaluate essential documents.

• Collect, monitor, and assess investigational site records pertaining to subject screening and enrollment.

• Support the development of study plans and status reports.

• Gather, monitor, and evaluate site regulatory documents.

• Aid in the creation and review of Informed Consent Forms.

• Engage with sites, clients, vendors, and internal study team members.

• Maintain the CTMS and other project management tools.

• Monitor study supplies and coordinate shipments to sites as necessary.

• Oversee the study Trial Master File and ensure regular TMF audits.

• Coordinate efforts with CRAs performing on-site monitoring.

• Conduct on-site co-monitoring and remote monitoring tasks.

• Review data entered by investigational site personnel in accordance with data review and monitoring protocols.

• Assist CRAs in resolving queries and conducting data reviews.

• Ensure compliance of studies with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations.

• Potentially mentor other team members.

⛳️ Requirements

• A Bachelor’s degree in a life science, nursing, or pharmacy field.

• Minimum of 1 year of direct experience managing essential documents within the CRO, pharmaceutical, or biotech sectors.

• Solid understanding of the clinical research process.

• Knowledge of regulatory and ethical submission processes for the designated countries.

• Familiarity with current ICH GCP guidelines and relevant regulations.

• Aspiration or career objective to transition into a traveling CRA position.

• Strong written, verbal, and presentation communication skills.

• Proficiency in both the local language and English.

• Attention to detail and a commitment to maintaining high scientific standards.

• Ability to work effectively and collaboratively with integrity and honesty.

• Critical thinking and objective assessment skills.

• Capability to adapt swiftly to evolving environments.

• Resume/CV must be submitted in English.

🏝️ Benefits

• Flexibility to maintain work-life balance.

• Supportive and collaborative work environment.

• Financial, workforce, and corporate stability.

• Opportunities for career growth and development.

• Chance to gain experience leading to a traveling CRA role.

• Potential mentoring opportunities.