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 https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job Category:** Professional **All Job Posting Locations:** Prague, Czechia **Job Description:** A senior CRA is a mid-level site management role with typically 3-5 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. The Senior CRA will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior CRA may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager 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 may participate in site feasibility and/or Site Qualification Visit. Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM. 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. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. May be required to help provide solutions to challenges faced in other sites in the country. 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 that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures accuracy, validity and completeness of data collected at trial sites 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. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. 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. **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 is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility. 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 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 consistently deliver clinical trials. Demonstrated capability to effectively communicate and engage with sites and sites personnel. Demonstrated problem solving capability.