PSI CRO AG logo
PSI CRO AG

The global CRO where clinical trials run on time.

Freelance Senior Clinical Research Associate

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 1,001-5,000Since 1996H1B No SponsorCompany SiteLinkedIn

Location

Slovakia

Posted

82 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Freelance Senior Clinical Research Associate

PSI CRO AG

Company Description PSI is a leading Contract Research Organisation with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance. This is a freelance (contractor) home-based position in Slovakia. Your responsibilities will include: - Conducting and reporting all types of onsite monitoring visits - Driving the study startup phase (if applicable) - Performing CRF reviews, source document verification and query resolution - Be responsible for site communication and management - Supervising study activities, timelines, and schedules for each site - Acting as a point of contact for in-house support services and vendors - Supporting quality control, such as compliance monitoring and reports review - Participating in feasibility research - Supporting the regulatory team in preparing documents for study submissions and regulatory approval Qualifications - BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience - Independent on-site monitoring experience in Slovakia, ideally on multiple projects at a time - Demonstrable experience in all types of monitoring visits in Phase II and/or III - Full and clean driver's license, and the ability to travel. - Fluency in Slovak and English - Experience supporting Oncology studies is beneficial, but not essential - Intermediate to Advanced knowledge of MS Office Additional Information Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.

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Germany
Full TimeRemoteTeam 1,001-5,000H1B No Sponsor

• Support pre-award feasibility projects • Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis. • Review clinical protocols, study assumptions, client information and study plans for US and global trials. • Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale. • Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information. • Undertake feasibility site outreach for pre award opportunities. • Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements. • Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery. • Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Poland
Full TimeRemoteTeam 1,001-5,000H1B No Sponsor

• Support pre-award feasibility projects • Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis. • Review clinical protocols, study assumptions, client information and study plans for US and global trials. • Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale. • Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information. • Undertake feasibility site outreach for pre award opportunities. • Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements. • Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery. • Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Spain