Cra (Level Ii)
hace 6 meses
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 monitoring 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 follow-up on findings as applicable. - Participates in investigator meetings as necessary. May help to identify 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 essential 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). - Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. - Maintains and 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 field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: - Basic medical/therapeutic area knowledge and understanding of medical terminology - Ability toattain and maintain a working knowledge of ICH GCPs and applicable regulations and - procedural documents - Good oral and written communication skills, with the ability to communicate effectively with medical personnel - Good interpersonal skills - 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 - Ability to remain flexible and adaptable in a wide range of scenarios - 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 - Ability to work in a team or independently as required - Good computer skills: solid knowledge of microsoft Office and the ability to learn appropriate software - Good English language and grammar skills Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
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Cra (Level I)
hace 8 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoCRA Level I or CRA Level II
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Cra (Level Ii)
hace 7 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoCRA with 1 year of experience in field monitoring - FSP position - Sponsor GSK
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Cra (Level I)
hace 3 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Per FSP CRA level I job description.
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Cra Ii
hace 7 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...
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Cra Ii
hace 2 meses
Buenos Aires, Argentina Icon plc A tiempo completoCRA II - Buenos Aires, Argentina 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 We are currently seeking a Clinical Research Associate II...
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All Cra Levels
hace 2 días
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...
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Cra Ii
hace 3 meses
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...
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Cra Ii
hace 7 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...
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Cra I, Cra Ii or Senior Cra, Single-sponsor
hace 2 meses
Buenos Aires, Argentina ICON Plc A tiempo completoCRA I, CRA II, Sr. CRA - Chile, Santiago 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 We are currently seeking a Clinical Research Associate...
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Cra Ii
hace 2 meses
Buenos Aires, Argentina Icon plc A tiempo completoCRA II - Buenos Aires, Argentina 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 diverse teams...
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Cra (Level I)
hace 3 meses
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office FSP CRA
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Cra Ii
hace 2 meses
Buenos Aires, Argentina ICON Plc A tiempo completoCRA II - Buenos Aires, Argentina 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 diverse teams...
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Cra (Level I)
hace 4 meses
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
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Cra Ii
hace 6 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,...
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Cra (Level Ii)
hace 2 días
Buenos Aires, Argentina PPD A tiempo completoPPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...
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Cra (Level Ii)
hace 1 día
Buenos Aires, Argentina PPD A tiempo completo**JOB DESCRIPTION**: PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and...
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Cra I, Cra Ii, or Senior Cra
hace 3 meses
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...
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Sr Cra
hace 9 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...
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Cra Ii
hace 7 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,...
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Cra Ii, or Senior Cra
hace 2 meses
Buenos Aires, Argentina ICON Plc A tiempo completoCRA 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 diverse...