- Participates in investigator meetings as necessary.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Provides trial status tracking and progress update reports to the team as required.
- Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.
- 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.
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Cra
hace 1 semana
Thermo Fisher Scientific Buenos Aires, ArgentinaAs a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site · management process. At PPD we hire the best, develop ourselves and each other, and recognize the · power of being one team. We offer continued career advancement opportunities, award w ...
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Cra
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Thermo Fisher Scientific Buenos Aires, ArgentinaEssential 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 decr ...
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Cra
hace 1 semana
Thermo Fisher Scientific Buenos Aires, ArgentinaMonitors 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 da ...
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ICON plc Buenos Aires, ArgentinaICON 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 ou ...
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Cra Ii
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Associate Cra
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Assistant Cra
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Thermo Fisher Scientific Buenos Aires, ArgentinaWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly ...
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Cra Ii
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ICON plc Buenos Aires, ArgentinaICON 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 ou ...
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Cra Ii
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ICON plc Buenos Aires, ArgentinaICON 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 ou ...
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Sr Cra
hace 6 días
Thermo Fisher Scientific Buenos Aires, ArgentinaMonitors 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. Ensu ...
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Cra I
hace 1 día
ICON plc Buenos Aires, ArgentinaICON 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 ou ...
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Cra 2
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IQVIA Buenos Aires, Argentinaconducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. · Essential Functions · - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance w ...
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Assoc Cra
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IQVIA Buenos Aires, ArgentinaJob Overview · Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. · **Ess ...
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Assoc Cra
hace 1 semana
Novasyte Buenos Aires, ArgentinaJob Overview · Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. · Essen ...
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Cra 2
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Novasyte Buenos Aires, Argentinaconducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. · Essential Functions · - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance w ...
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Sr Cra
hace 10 horas
Thermo Fisher Scientific Buenos Aires, ArgentinaMay assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Works on problems of moderate scope wher ...
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Lead Cra
hace 1 semana
PSI CRO Buenos Aires, Argentina**Company Description** · We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on ...
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Cra 2
hace 1 semana
IQVIA Buenos Aires, ArgentinaJob Overview · Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. · Essential Functions · - Perform site monito ...
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16254-cra 2
hace 1 semana
IQVIA Buenos Aires, Argentina**CRA 2 - Homebased** · Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentor ...
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16254-cra 2
hace 1 semana
Novasyte Buenos Aires, ArgentinaCRA 2 - Homebased · Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring ...
CRA (Level I) - Buenos Aires, Argentina - Thermo Fisher Scientific
Descripción
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 different sponsors and/or monitoring 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.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 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 follows-up on findings as applicable.requirements/audits/inspections.
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.