Clinical Research Associate

hace 4 semanas

Bogota, Colombia MSD A tiempo completo

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new sites.

Participates in internal meetings and workstreams as SME for monitoring processes and systems.

**Responsibilities include, but are not limited to**:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs co-monitoring visits where appropriate.
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
- Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

**CORE Competency Expectations**:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.

**Behavioural Competency Expectations**:

- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Demonstrated high level of monitoring skill with independent professional judgement.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set.
- Positive mindset, growth mindset,

  • Associate Clinical Research Associate

    hace 3 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...

  • Clinical Research Associate

    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 Research Associate

    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 Research Associate

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and...

  • Clinical Research Manager

    hace 1 semana

    Bogota, Colombia Novo Nordisk A tiempo completo

    Clinical Research Manager **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - As Clinical Research Manager you will manage and coordinate the implementation of local clinical projects, ensuring that are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki...

  • Clinical Research Associate

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

  • Clinical Research Associate

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and...

  • Senior Clinical Research Associate

    hace 2 semanas

    Bogota, Colombia Novo Nordisk A tiempo completo

    Senior Clinical Research Associate **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - The Senior CRA will manage and execute the entire Novo Nordisk clinical trials process in compliance with internal SOPs including GCP-ICH and Colombia regulatory framework.**Activities and Responsibilities** - Clinical Trials...

  • Clinical Research Associate

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and procedures, quality...

  • Clinical Research Associate

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Sr. Clinical Research Associate

    hace 2 meses

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Manager

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Clinical Research Manager could be responsible for a particular study...

  • In-house Clinical Research Associate I

    hace 3 semanas

    Bogota, Colombia Labcorp 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...

  • Senior Clinical Research Associate

    hace 2 meses

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

  • Senior Clinical Research Associate

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Associate

    hace 5 días

    Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

  • Associate Clinical Research Associate

    hace 3 días

    Bogota, Colombia MSD A tiempo completo

    With support of Sr CRA/CRA and/or CRA 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 relationships through all phases of the trial. - Performs clinical study site management/monitoring...

  • Clinical Research Associate

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Associate Country Clinical Quality Manager

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover...

  • Senior Clinical Research Manager

    hace 5 días

    Bogota, Colombia MSD A tiempo completo

    This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Senior Clinical Research Manager could be responsible for a particular study for several...