Cra (Level I)

hace 5 meses

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

**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 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.
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 to attain 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 flexibile 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

  • Cra (Level I)

    hace 7 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA Level I or CRA Level II

  • Cra (Level I)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

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

  • Cra (Level I)

    hace 3 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

  • Cra (Level I)

    hace 2 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office FSP CRA

  • Cra (Level Ii)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

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

  • Cra (Level I)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    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 energetic teams. Our global...

  • Cra I, Cra Ii or Senior Cra, Single-sponsor

    hace 2 semanas

    Buenos Aires, Argentina ICON Plc A tiempo completo

    CRA 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...

  • Cra I, Cra Ii, or Senior Cra

    hace 2 meses

    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 3 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office 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...

  • Ihcra I

    hace 6 meses

    Buenos Aires, Argentina Fortrea - Organic A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Cra (Level I)

    hace 1 semana

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Bachelor's degree preferred. GCP Course. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6 moths to 1.5 years).

  • Cra (Level I)

    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 I)

    hace 3 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office 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...

  • Cra (Level I)

    hace 6 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Summarized Purpose: Performs and coordinates different aspects of the clinical monitoring and site management process. 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...

  • Cra Ii

    hace 6 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...

  • Senior Cra

    hace 2 semanas

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Senior CRA - Argentina, Buenos Aires 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 Senior Clinical Research...

  • Clinical Research Associate

    hace 7 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 fulfill 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 organization: Accountability &...

  • Sr Cra

    hace 8 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 6 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...

  • Coordinating Cra

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Coordinating CRA (CCRA) PURPOSE OF THE ROLE To take the lead on behalf of the CFSP Clinical Monitoring department, as representative on the Study Team for our function. Responsible for operational management of a team of Monitors from start up, to ensure consistent monitoring quality and adherence to Trial timelines across all regions, through to database...