Sr. CRA 1, Oncology, Brazil

3 semanas atrás

São Paulo, São Paulo, Brasil BZL IQVIA RDS Brasil Ltda Tempo inteiro

IQVIA Biotech is seeking a Sr. CRA 1 located in Brazil with at least 2 years of on-site monitoring in oncology:

Essential Job Functions, Duties and Responsibilities:


• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.


• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.


• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.


• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.


• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.


• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.


• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.


• Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.


• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications


• Bachelor's Degree in scientific discipline or health care preferred.


• Requires at least 2 years of year of on-site monitoring experience.


• Equivalent combination of education, training and experience may be accepted in lieu of degree.


• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.


• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.


• Good therapeutic and protocol knowledge as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

#J-18808-Ljbffr

  • Central Monitor, Brazil, Oncology, Biotech

    3 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    OverviewJoin to apply for the Central Monitor, Brazil, Oncology, IQVIA Biotech role at IQVIA. IQVIA Biotech is hiring for Sr. CRA 1 and CRA 2 located in Brazil with at least 1 year of on-site monitoring in oncology.IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically...

  • Central Monitor, Brazil, Oncology, Biotech

    2 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Overview Join to apply for the Central Monitor, Brazil, Oncology, IQVIA Biotech role at IQVIA. IQVIA Biotech is hiring for Sr. CRA 1 and CRA 2 located in Brazil with at least 1 year of on-site monitoring in oncology. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically...

  • Fellow In Neuro-Oncological Surgery

    1 semana atrás

    São Paulo, São Paulo, Brasil A.Co Cancer Center Tempo inteiro

    Overview2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from A.C.Camargo Cancer CenterRoleNeurosurgeon - Member of the Brazilian Society of NeurosurgerySeniority levelInternshipEmployment typeOtherJob functionHealth Care ProviderIndustriesHospitals and Health CareReferrals...

  • Sr site activation specialist assigned to client Home Based Brazil

    2 semanas atrás

    São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

    Overview Sr site activation specialist assigned to client Home Based Brazil Join to apply for the Sr site activation specialist assigned to client Home Based Brazil role at Syneos Health Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...

  • Sr site activation specialist assigned to client Home Based Brazil

    2 semanas atrás

    São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

    OverviewSr site activation specialist assigned to client Home Based BrazilJoin to apply for the Sr site activation specialist assigned to client Home Based Brazil role at Syneos HealthResponsibilitiesGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...

  • Sr site activation specialist assigned to client Home Based Brazil

    2 semanas atrás

    São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

    OverviewSr site activation specialist assigned to client Home Based BrazilJoin to apply for the Sr site activation specialist assigned to client Home Based Brazil role at Syneos HealthResponsibilitiesGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...

  • Fellow In Neuro-Oncological Surgery

    1 semana atrás

    São Paulo, São Paulo, Brasil A.Co Cancer Center Tempo inteiro

    Overview 2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from A.C.Camargo Cancer Center Role Neurosurgeon - Member of the Brazilian Society of Neurosurgery Seniority level Internship Employment type Other Job function Health Care Provider Industries Hospitals and...

  • Sr CRA I

    4 semanas atrás

    São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

    Join to apply for the Sr CRA I - Sponsor dedicated - São Paulo, Brazil Home Based role at Syneos Health 1 day ago Be among the first 25 applicants Join to apply for the Sr CRA I - Sponsor dedicated - São Paulo, Brazil Home Based role at Syneos Health Get AI-powered advice on this job and more exclusive features. DescriptionSr CRA I - Sponsor dedicated...

  • Sr CRA I

    2 semanas atrás

    São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

    Join to apply for the Sr CRA I - Sponsor dedicated - São Paulo, Brazil Home Based role at Syneos Health1 day ago Be among the first 25 applicantsJoin to apply for the Sr CRA I - Sponsor dedicated - São Paulo, Brazil Home Based role at Syneos HealthGet AI-powered advice on this job and more exclusive features.DescriptionSr CRA I - Sponsor dedicated - São...

  • Central Monitor, Brazil, Oncology, Biotech

    3 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    IQVIA Biotech is seeking a Sr. CRA 1 and CRA 2 located in Brazil with at least 1.5 years of on-site monitoring in oncology: Essential Job Functions, Duties and Responsibilities: • Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. • Work with...