In-House Clinical Research Associate

This is a fully remote position, open to applicants in Poland.

📋 Description

• Gather, monitor, and assess investigational site records related to subject screening and enrollment.

• Support the creation of study plans and status updates.

• Collect, oversee, and evaluate all site regulatory documents.

• Assist in the formulation and examination of Informed Consent Forms.

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

• Manage the clinical trials management system (CTMS) and other project tracking applications.

• Monitor study supplies and organize shipments of materials to sites as necessary.

• Administer the study Trial Master File (TMF) and ensure regular TMF audits.

• Coordinate activities with CRAs monitoring on-site.

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

• Perform routine evaluations of data entered by investigational site personnel in accordance with data review/monitoring standards.

⛳️ Requirements

• Bachelor's Degree in a life science, nursing, or pharmacy field, complemented by a minimum of 1 year of direct experience managing essential documents within the CRO, pharma, or biotech sectors.

• Strong understanding of the clinical research process along with knowledge of Regulatory and Central/Local ethical submission procedures for designated countries; familiarity with current ICH GCP guidelines and relevant regulations.

• Motivation to advance into a traveling CRA position.

• Excellent Communicator: Exhibit written, verbal, and presentation skills to effectively convey the achievements of your work and Rho’s; proficiency in both the local language and English.

• Commitment to Quality: Every role at Rho demands meticulous attention to detail, a comprehensive understanding of our rigorous scientific standards, and a genuine concern for every outcome.

• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we cherish a strong team ethos characterized by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we share laughter. We own our actions, forgive honest mistakes, and respect one another.

• Critical Thinker: Rho appreciates thoughtful analysis. Leverage your innate creativity, honed by our knowledge, training, and experience. We assess situations and opportunities with objectivity and precision; then we devise innovative, practical solutions.

• Agile and Adaptable: Rho values quick adaptability. We proactively anticipate, respond to, and capitalize on changes in our environment. We embrace risk while managing it through planning and learning from both successes and failures. The chance to adapt and grow invigorates us.

🏝️ Benefits

• Flexibility: We promote a work-life balance that empowers employees to bring their best selves to work while nurturing their passions outside of work.