Clinical Research Associate 2

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

📋 Description

• Oversee the identification, feasibility evaluation, and selection of investigators and sites to conduct the trial.

• Carry out all monitoring activities as outlined in the Monitoring Plan, including the timely completion of monitoring visit reports.

• Prepare, schedule, organize, and perform site evaluation visits, providing reports to aid in site selection.

• Prepare, submit, and/or collaborate with regulatory specialist colleagues to create regulatory packages, manage import/export requirements, and update Ethics Committee packages.

• Negotiate site budgets, coordinate site contract execution, track invoicing, and ensure prompt site payments.

• Prepare, plan, organize, and conduct site initiation visits.

• Create and maintain relevant monitoring tools and project-specific documentation.

• Inspire and train investigators to ensure trial site personnel thoroughly understand the protocol, investigational product, and trial requirements to fulfill their responsibilities accurately and timely.

• Collect, review, and approve essential documents from trial sites to guarantee quality and compliance, and organize documents for Trial Master File (TMF) filing.

• Reconcile the contents of the in-house TMF with the site’s Investigator Site Files.

• Coordinate the distribution, tracking, handling, and disposal of investigational products and other trial supplies according to site/trial requirements.

• Maintain trial information utilizing the clinical trial management system and any other tracking and reporting tools applicable to the trial.

• Support initiatives aimed at enhancing recruitment efforts.

⛳️ Requirements

• Degree in a related science or healthcare field.

• Prior experience in clinical trials within an academic, CRO, or pharmaceutical setting, with 2-5 years of on-site monitoring and site management experience being essential.

• Experience in renal/nephrology and oncology studies.

• Practical knowledge of ICH-GCP guidelines and both global and local ethical and regulatory research requirements.

• Proficiency in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.

• Competence in essential business skills: negotiation and conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Strong interpersonal communication and presentation skills, along with the ability to work effectively within a multi-disciplinary team and engage with a diverse range of stakeholders both autonomously and collaboratively.

• Ability to adapt and be flexible in response to changing organizational priorities and uncertain environments.

• Willingness and ability to travel.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Enjoy hybrid or remote working arrangements based on your location and role.

• Career Growth: Access a wealth of learning opportunities and a global network of scientific leaders to support your professional development.

• Employee Wellbeing: Participate in programs and initiatives designed to enhance work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building activities.

• Global Opportunities: Join a company with a worldwide presence, offering exposure to a variety of projects and clients.