Johnson & Johnson Careers
Clinical Research non-MD
Requisition ID: 1805688015W
• Participates in site feasibility and/or pre-trial site assessment visits, providing. recommendation from local area about site/investigator selection in collaboration with the trial team.
• Acts as primary local company contact for assigned sites for specific trials.
• Attends/participates in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-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.
• Arranges for the appropriate destruction of clinical supplies.
• Ensures site staff complete the data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites.
• Ensures that all AEs/SAEs/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 systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints.
• Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Follows the corresponding Monitoring Guidelines for each assigned trial.
• Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Attends regularly scheduled team meetings and trainings.
• Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
• Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g…,OSQMV.
• Prepares trial sites for close out, conduct final close out visit.
• Negotiates investigator budgets at site level, if applicable.
• 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.
• May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
• Act as an point of contact in site management practices.
• May be assigned as a coach and mentor to a less experienced site manager.
• May contribute to process improvement and training.
• Leads and/or participates in special initiatives as assigned.
• May assume additional responsibilities or special initiatives such as “Champion” or Therapeutic Area Expert”.
• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 2 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.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, 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 skills.
J&J (China) Investments Ltd A- Beijing Branch (7075)
Clinical Research non-MD