Clinical Trial Coordinator

hace 3 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 applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA.

Responsibilities include, but are not limited to:
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

Trial and site administration:

- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles

Document management:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders

Meeting Planning:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings

Qualification & Experience:

- Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role
- Minimum 1 year of experience.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R246315

  • Clinical Trial Coordinator

    hace 19 horas

    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 Assistant

    hace 19 horas

    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...

  • Clinical Trial Coordinator

    hace 19 horas

    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 19 horas

    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 3 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 &...

  • Associate Clinical Research Associate

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: With support of Sr Clinical Research Associate/Clinical Research Associate and/or Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site...

  • Practicante Clinical Trial Operations

    hace 3 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** -...

  • Clinical Operations Coordinator

    hace 4 días

    Bogota, Colombia Insight Therapy Solutions A tiempo completo

    **Clinical Operations Coordinator** **Work set-up**: Remote **About Us** We are a rapidly evolving mental health clinic with a small clinic culture and a tech company vision. We evolved from a traditional physical location to a tech-driven company during the pandemic, but have maintained our warm and collaborative culture. **The role** Seeking a skilled...

  • Clinical Research Manager

    hace 2 semanas

    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...

  • Senior Clinical Data Coordinator

    hace 3 días

    Bogota, Colombia ICON 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...