CRA II Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
CRA II Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005926Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHEREJob responsibilitiesPerforms 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 Pharmacoepidemiology Practice (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 develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and completeApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesUtilizes available hardware and software to support the effective conduct of the clinical study data review and captureVerifies site compliance with electronic data capture requirementsMay perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.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.Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.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 to changing priorities to achieve goals / targets.May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 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.Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-outKnowledge of local requirements for real world late phase study designsChart abstraction activities and data collectionCollaboration with Sponsor affiliates, medical science liaisons and local country staffThe SMA II may be requested to train junior staffIdentify and communicate out of scope activities to Lead CRA/Project ManagerProactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associationsQualificationsWhat 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 manage required travel of up to 75% on a regular basisAt Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.
#J-18808-Ljbffr
-
CRA II Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health, Inc. A tiempo completoCRA II Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Madrid-Calle-Hernani-59Job ID:24005926Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...
-
CRA II Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 1 semana
España Syneos Health, Inc. A tiempo completoSr CRA I Barcelona or Madrid. Sponsor dedicated.Updated: October 29, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24005837Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health, Inc. A tiempo completoSr CRA I Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005911Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health, Inc. A tiempo completoSr CRA I Barcelona or Madrid. Sponsor dedicated.Updated: October 29, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005837Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health Healthcare Careers A tiempo completoSr CRA I Barcelona or Madrid. Sponsor dedicated.Syneos Health Healthcare Careers – Madrid, MadridSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical...
-
CRA II
hace 3 semanas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
-
CRA II
hace 3 semanas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Research Associate II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
-
España Syneos Health A tiempo completoDescriptionClinical Research Associate IISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Senior Clinical Research Associate I Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...
-
Sr CRA I Barcelona or Madrid. Sponsor dedicated.
hace 1 semana
España Syneos Health A tiempo completoDescriptionSenior Clinical Research Associate ISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to...
-
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
-
España Syneos Health Healthcare Careers A tiempo completoCRA II Madrid. Experience in Neurology. Sponsor dedicated.Syneos Health Healthcare Careers – Barcelona, BarcelonaSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our...
-
Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health, Inc. A tiempo completoClin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24005923Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to...
-
Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health, Inc. A tiempo completoClin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005923Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to...
-
España Syneos Health, Inc. A tiempo completoSr Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24005922Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes...
-
España Syneos Health, Inc. A tiempo completoSr Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005922Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to...
-
Clinical Research Associate
hace 6 meses
España Avania A tiempo completoAvania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that...
-
Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos Health A tiempo completoDescription Clinical Operations Specialist Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
-
Clin Ops Specialist. Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Operations Specialist Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
