CRA I (United States)
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Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Ensures the integrity of clinical data and adherence to applicable Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
* Communication - Maintains timely and effective communication among team members and site staff. Anticipates/indentifies potential issues.
* Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested; may require guidance to respond to findings. May be responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities.
* Monitoring - Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; and regularly reviews the status of the contents within the site regulatory binder.
* Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Utilizes multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
* Reporting and Tracking - Completes and submits visit reports according to SOP/Works Instructions (WI) requirements. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
* Administrative - Prepares for and attends Investigator meetings; may present materials, as requested. Assists with the preparation of study start up materials and tools. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
Performs other work-related duties as assigned. Extensive travel may be required (more than 50%).
BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Previous clinical or related research experience preferred. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines; basic knowledge of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. null