Cra 1
hace 4 días
**JOB OVERVIEW**
- Job Profile Summary_
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.
**Responsibilities**
- Essential Functions_
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
-
Cra 1
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 4 días
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 4 días
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1 Unblinding
hace 6 días
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 4 semanas
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 6 días
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Cra 1
hace 3 semanas
Desde casa, México IQVIA A tiempo completo**Job 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 monitoring visits (initiation, monitoring and close-out visits) in accordance with...
-
Cra I
hace 6 días
Desde casa, México ICON A tiempo completoAs a Clinicla Resear Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and...
