- Assures the implementation of project plans as assigned.
- Site administration and site monitoring responsibility for clinical studies according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP.
- Site management responsibility for clinical studies according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP.
- Act in the project role of as Local Project Coordinator or Lead CRA as assigned.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- General On-Site Monitoring Responsibilities
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
- Ensure the resources of the Sponsor and ESTERN Medical are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to ESTERN Medical travel policy.
- Prepare accurate and timely trip reports.
- Responsible for all aspects of site management as prescribed in the project plans.
- Responsible for all aspects of registry management as prescribed in the project plans.
- Undertake feasibility work when requested.
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor.
- Negotiate study budgets with potential investigators and assist the ESTERN Medical legal department with statements of agreements as assigned.
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently perform CRF review; query generation and resolution against established data review guidelines on ESTERN Medical or client data management systems as assigned by management.
- Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
- Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
- Perform other duties as assigned by management.
- Travel required 15-35%
- Education/Qualifications
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Full understanding of the clinical trial process.
- Thorough knowledge of ESTERN Medical S.O.P.s for site monitoring.
- Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
- In lieu of the above requirements, candidates with three (3) years of site management and/or study coordinator experience will be considered.
- Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good planning, organization and problem solving abilities.
- Ability to work with minimal supervision.
- Good communication and interpersonal skills.
- Good analytical and negotiation skills.
- Computer competency.
- Fluent in English & Spanish, both written and verbal.
- Works efficiently and effectively in a matrix environment
- Three (3) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- May be filled as an CRA II or CRA III, depending on background and experience.
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Regional Clinical Research Associate Level II - México - ESTERN Medical LLC
Descripción
Regional Clinical Research Associate Level II & III Mexico Business Title
Regional Clinical Research Associate Level II & III
Requisition ID
EM-R-CRA-1003
Job Category
Regional Clinical Research
