Empleos actuales relacionados con CRA (Level II) - Buenos Aires - Thermo Fisher Scientific
-
Cra (Level I)
hace 5 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoCRA Level I or CRA Level II
-
Cra (Level I)
hace 4 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoCRA I or CRA II (1-2 years of experience)
-
Cra (Level Ii)
hace 4 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoCRA with 1 year of experience in field monitoring - FSP position - Sponsor GSK
-
Cra Ii
hace 4 meses
Buenos Aires, Argentina ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
Cra Ii
hace 2 semanas
Buenos Aires, Argentina Icon plc A tiempo completoCRA II - Buenos Aires, Argentina - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our...
-
Cra Ii
hace 4 meses
Buenos Aires, Argentina ICON plc A tiempo completo**Senior Clinical Research Associate - Home-based role** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the...
-
Cra Ii
hace 4 meses
Buenos Aires, Argentina ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Cra (Level I)
hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office FSP CRA
-
Cra (Level I)
hace 3 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Please review Job description for FSP CRA I
-
Cra Ii
hace 3 meses
Buenos Aires, Argentina ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Cra I, Cra Ii, or Senior Cra
hace 1 semana
Buenos Aires, Argentina Icon plc A tiempo completoCRA I, CRA II, or Senior CRA (Single-Sponsor) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our...
-
Sr Cra
hace 6 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoMonitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and...
-
Cra Ii
hace 4 meses
Buenos Aires, Argentina ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Cra Ii
hace 4 meses
Buenos Aires, Argentina ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Cra Ii
hace 3 meses
Buenos Aires, Argentina ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Senior Clinical Research Associate Ii
hace 4 meses
Buenos Aires, Argentina Fortrea A tiempo completoMust have a Bachelor's Degree (or equivalent) with 6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs- Advanced site monitoring skills- Advanced study site management...
-
Cra (Level Ii)
hace 3 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo**Essential Functions**: - Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as...
-
Cra (Level Ii)
hace 3 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completodata accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical...
-
Cra (Level Ii)
hace 3 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Cra (Level Ii)
hace 6 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and...
CRA (Level II)
hace 4 meses
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from sponsor GSK and/or supervising environments ( FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Key responsibilities
-Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
-Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
-Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
-Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions ( Clinical Trial Management System).
-Facilitates effective communication between investigative sites, the client company and the CRG project team through written, oral and/or electronic contacts.
-Responds to company, client and applicable regulatory requirements/audits/inspections.
-Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
-Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
-Contributes to other project work and initiatives for process improvement, as required.
Education and Experience:
-Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
-Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of CRG Drug Development Fellowship. Valid driver's license where applicable.
Knowledge, Skills and Abilities:
-Proven clinical monitoring skills.
-Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
-Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
-Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
-Ability to manage Risk Based Monitoring concepts and processes.
-Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
-Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
-Good organizational and time management skills
-Effective interpersonal skills.
-Attention to detail.
-Ability to remain flexible and adaptable in a wide range of scenarios.
-Ability to work in a team or independently as required.
-Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
-Good English language and grammar skills.
-Good presentation skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with CRG, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
