Remote Clinical Research Associate
hace 1 semana
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and friendliest people in the sector, and you’ll be helping shape an industry.
**What will you be doing?**
The Remote Clinical Research Associate is responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs, and all applicable rules and regulations. The responsibilities of this position include but are not limited to identifying, training/initiating, and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.
**The Role Responsibilities**:
- Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients, and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business, and meeting client needs.
- Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary.
- Serves as the primary contact for sites and investigators participating in studies.
- Acts as a resource for internal study teams and other ICON departments
Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others), and other site management documents.
- Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan.
- Participates in QA audits as needed.
- Regularly attends and contributes to project-specific and departmental meetings
Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time.
- Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs.
- Maintains and archives study documentation and correspondence, as needed.
- Assists with site contracting process, as needed.
- Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
- With support, demonstrates the ability to manage site assignments and workload
Maintains Sponsor and patient confidentiality.
- Actively participates in regular meetings with Project Managers or delegates, and/or RS
**Lead**:
- Assists in the development of site and patient enrolment strategies with the project team; works to motivate sites to meet enrolment timelines.
- Developing knowledge of and compliance with local regulatory requirements.
- Compliant and current with departmental and corporate policies and procedures.
**Communication**:
- Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, and proactive interaction with the study team and site staff.
- Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects other's point of view, and seeks advice when appropriate.
**Business Development**:
- Supports the formation of relationships with internal and external customers.
- May attend bid defense presentations, as needed.
- Supports internal and external capabilities presentations.
**Teamwork**:
- Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets.
- Follows departmental policies and procedures.
Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
- Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives.
- Maintains professional interpersonal relationships with team, sites, and Sponsor.
**Personal/Professional Development**:
- Increases knowledge of therapeutic areas, GCP, and any applicable local regulatory requirements.
- Seeks opportunities to demonstrate leadership and enhance own professional growth.
- Actively participates in Lunch and Learns, Journal Clubs, or other internal company t
-
Clinical Research Associate
hace 4 días
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” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations...
-
Clinical Research Associate
hace 2 semanas
Bogota, Colombia MSD A tiempo completoThe 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...
-
Senior Clinical Research Associate
hace 1 semana
Bogota, Colombia Novo Nordisk A tiempo completoSenior 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 Manager
hace 1 semana
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...
-
Senior Clinical Research Associate
hace 1 semana
Bogota, Colombia MSD A tiempo completoThe 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...
-
In-house Clinical Research Associate I
hace 2 semanas
Bogota, Colombia Labcorp A tiempo completoAs 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...
-
Clinical Research Associate
hace 5 días
Bogota, Colombia AstraZeneca A tiempo completo¿Tienes experiência y pasión por estudios clínicos? ¿Te gustaría aplicar tu experiência para impactar en una empresa que sigue la ciencia y convierte las ideas en medicamentos que cambian la vida? ¡Entonces AstraZeneca podría ser la empresa indicada para ti!_ En el Clúster Andino tenemos una gran oportunidad dentro del área de estudios clinicos...
-
Clinical Research Manager
hace 1 semana
Bogota, Colombia MSD A tiempo completoThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for...
-
Clinical Research Manager
hace 4 días
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 a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a...
-
Senior Clinical Research Associate
hace 1 semana
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 or CRD, 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...