Clinical Trial Assistant

hace 3 días

Bogota, Colombia IQVIA A tiempo completo

Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

**Qualifications**:

- High School Diploma or equivalent
- 3 years administrative support experience.
- Equivalent combination of education, training and experience.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.

  • Clinical Trial Coordinator

    hace 3 días

    Bogota, Colombia MSD A tiempo completo

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Trial Coordinator

    hace 5 días

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...

  • Clinical Trial Coordinator

    hace 1 semana

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that...

  • Clinical Trial Coordinator

    hace 3 días

    Bogota, Colombia MSD A tiempo completo

    Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is...

  • Clinical Trial Manager Ii

    hace 3 días

    Bogota, Colombia Icon plc A tiempo completo

    Clinical Trial Manager II JR090304 Site: Peru / Brazil / Chile / Colombia / Mexico 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...

  • Sr. or Clinical Trial Manager, Oncology, Columbia

    hace 5 días

    Bogota, Colombia Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...

  • Data Management Trial Manager

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Position Overview**: The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable. Collaborates with...

  • Data Management Trial Manager

    hace 1 semana

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. The Trial Manager creates and ensures the successful...

  • Practicante Clinical Trial Operations

    hace 5 días

    Bogota, Colombia MSD A tiempo completo

    ¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas? ¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento! **Estas son algunas de las funciones que realizarás como practicante de Clinical Trial Operations** -...

  • Head Clinical Country Operations

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    This role is accountable for execution and oversight of local operational clinical trial activities in compliance with International Conference on Harmonization Good Clinical Practice (ICH/GCP) and country regulations, company policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on local...