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Cra I Madrid. Oncology Experience. Sponsor Dedicated TUD-458
Responder al anuncioCRA I Madrid. Oncology experience. Sponsor dedicated - (22005499)
Description
Clinical Research Associate I
Come discover what our 25, 000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves.
- Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you.
- That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with.
- Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
Job responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
- Verifies site compliance with electronic data capture requirements.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I.
Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real world late phase study designs.
- Chart Abstraction activities and data collection.
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff.
Qualifications
What we’re looking for
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to work independently and as part of a team.
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