Clinical Research Associate II

We are currently hiring a Clinical Research Associate II or Sr. CRA to join our thriving team in Poland!

Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. Dokumeds is now part of Rho, and, as one thriving company, we will deliver global full-service clinical development services and unmatched customer support – worldwide.

Responsibilities:

Conduct Clinical study according to Sponsor requirements based on excellent knowledge of Good Clinical Practice, Protocol and applicable regulations:

• Serve as your country’s clinical research industry subject matter expert
• Plan and perform Site visits (SIV, SMV and SCOV) and site management activities to ensure compliance with Project Management plan and Protocol
• Help to plan and perform Country and Site Feasibility, including assessment of potential Risks and challenges, as well as select Study sites and perform pre-study visits
• Assist in selection of Study specific Vendors and perform Vendor assessments
• Support in negotiation and execution of Investigator/ Institution contracts
• May help to prepare documents submission to Ethics Committee, Competent Authorities and other bodies (as applicable), including communication with Sponsor, EC/ CA and other involved parties
• Provide input in supportive Study specific processes, e.g., Study supplies management, patient reimbursement management etc.

Qualifications:

• University degree in medicine, pharmacy, nursing or life science
• Minimum 2 years of previous on-site monitoring experience in CRO or Pharma company
• Previous study start-up experience, including but not limited to country and site feasibility, Investigator/ Institution agreement management, submissions to Ethics Committees/ Regulatory Authorities (including initial submissions) is preferred.
• Advanced knowledge of applicable country clinical research regulatory guidelines
• Thorough knowledge of ICH-GCP guidelines
• Excellent knowledge of both English and local languages
• Availability to travel
• Computer literacy
• Driving license
• Strong organizational, communication and teamwork skills, ability to set priorities independently
• Courage and initiative to try new and innovative things, ability to take responsibility, acknowledge and learn from mistakes
• Creativity, enthusiasm, and flexibility