Senior Clinical Research Associate

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Prague, Czechia

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

Johnson & Johnson is currently seeking a Senior Clinical Research Associate (Site Manager) to join our Global Clinical Operations team located in Prague, Czech Republic.

Senior Clinical Research Associate (Site Manager) is a role with typically min. 5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior CRA is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. A Senior CRA may contribute to process improvement, training and mentoring of other Site Managers. A Senior CRA is generally expected to be able to operate independently with little or limited supervision.

Principal Responsibilities:

• Acts as primary local company contact for assigned sites for specific trials.
• Actively participates in site feasibility and/or Site Qualification Visit.

• Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with little or limited supervision.

• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.-

• Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.

• Ensures site staff complete data entry and resolve queries within expected timelines.

• Proactively ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.-

Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.

• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Prepares trial sites for close out, conduct final close out visit.
• Tracks costs at site level and ensure payments are made, if applicable.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
• Occasionally leads and/or participates in special initiatives as assigned.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
• 3-5 years of clinical trial monitoring experience
• Specific therapeutic area experience may be required depending on the position and is an added advantage.
• Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and ability to learn company systems.

• Willingness to travel with occasional overnight stay away from home.

• Proficient in speaking and writing the country language and English. Good written and oral communication.-

• Ability to work on multiple trials in parallel.

• Demonstrated capability to effectively communicate and engage with sites and sites personnel.
• Demonstrated problem solving capability.