Empleos actuales relacionados con Cra (Level Ii) - Buenos Aires - Thermo Fisher Scientific

  • Cra (Level I)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA Level I or CRA Level II

  • Cra (Level I)

    hace 4 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA I or CRA II (1-2 years of experience)

  • Cra (Level Ii)

    hace 4 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA with 1 year of experience in field monitoring - FSP position - Sponsor GSK

  • Cra Ii

    hace 4 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    ICON 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 completo

    CRA 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 completo

    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 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 completo

    At 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 completo

    CRA 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 completo

    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...

  • Cra Ii

    hace 4 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    At 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 3 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    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 centre of all that we do, we help to accelerate the development...

  • Cra Ii

    hace 4 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    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 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 completo

    Must 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 completo

    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...

  • Cra (Level Ii)

    hace 3 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    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...

  • Cra (Level Ii)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    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...

Cra (Level Ii)

hace 4 meses

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

Essential Functions:

  • Monitors investigator sites with a riskbased monitoring approach applies root cause analysis (RCA), critical thinking and problemsolving 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 onsite and remote monitoring activities.
  • Assess investigational product through physical inventory and records review. Documents observations in reports and letters promptly 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 on time.
  • 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 followsup on findings as applicable.
  • Participates in investigator meetings as necessary. 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 closeout and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conducts onsite 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 (e.g. Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and the PPD 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.

Qualifications:

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
:

  • 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 PPD Drug Development Fellowship
:

  • 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:

  • Confirmed clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
  • Welldeveloped critical thinking skills, including but not limited to: critical mindset, indepth 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 flexibile and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as require
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills
  • Good presentation skills

Working Conditions and Environment:

  • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
  • Frequent drives to site locations.
  • Frequent travel, generally 6080% but more for some individuals. May also include extended
overnight stays.

  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Personal protective equipment required su