Clinical Research Associate

hace 11 horas

Santiago de Chile 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, our 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.

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 regulations, 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: o Data generated at site are complete, accurate and unbiased. o 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 Escalation Pathway as appropriate in collaboration with leadership as needed.
- Works in partnership with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, headquarter functional areas and externally with vendors and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert, 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 Clinical Research Director and/or Clinical Reseach Associates manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Experience Requirements:
Required: - Min. 2 years of direct site management (monitoring) experience

in a bio/pharma/CRO.

Educational Requirements:
Preferred: B.A./B.S. with strong emphasis in science and/or biology

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R235255

  • Senior Clinical Research Associate — Remote Trial Lead

    hace 2 semanas

    Santiago, Chile ICON A tiempo completo

    A global healthcare intelligence organization is seeking a Senior Clinical Research Associate (CRA) in Santiago, Chile. The successful candidate will oversee clinical trial activities ensuring compliance with protocols and industry standards. Responsibilities include monitoring trial sites, conducting site visits, and collaborating with cross-functional...

  • Clinical Site Operations Associate I

    hace 3 semanas

    , Región Metropolitana de Santiago, Chile PSI CRO A tiempo completo

    A global clinical research organization is seeking a professional to support clinical research projects in Santiago, Chile. The role involves managing communication between site personnel and the clinical research associates, ensuring compliance with local regulations, and managing clinical supplies. The ideal candidate holds a degree in life sciences, has...

  • Clinical Research Associate

    hace 1 semana

    Santiago de Chile MSD A tiempo completo

    **Job Description**: Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company "“ one that is ready to help create a healthier future for all of us. Responsibilities include, but not limited to: - Acts as primary site...

  • Senior Clinical Research Associate

    hace 6 días

    Santiago de Chile Parexel A tiempo completo

    **We are looking for passionate professionals with sufficient experience to become Sr CRA, to work in Chile supporting onsite monitoring in Chile, Argentina, and some remotely.** **Your time here** At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build...

  • Clinical Research Associate

    hace 1 semana

    Santiago, Metropolitana, Chile Levita Magnetics A tiempo completo

    Levita Magneticsestá transformando la cirugía mínimamente invasiva a través deMagnetic Surgeryy su robot quirúrgicoMARS. Operamos en un entorno ágil y dinámico, con un portafolio en crecimiento de productos innovadores.Como parte del crecimiento de Levita Magnetics en Latinoamérica, actualmente estamos buscando un/aClinical Research Associate (CRA)...

  • Hybrid Clinical Research Associate II — Chile

    hace 7 horas

    Santiago, Chile ICON A tiempo completo

    A world-leading healthcare organization is seeking a Clinical Research Associate II to join their team in Santiago, Chile. This role involves managing clinical trials, ensuring compliance, and collaborating with site staff. Candidates must have a bachelor's degree in a scientific or healthcare field and at least 2 years of experience. Exceptional...

  • Associate Clinical Lead

    hace 1 semana

    Santiago, Chile IQVIA A tiempo completo

    A leading global healthcare company seeks an Associate Clinical Lead based in Santiago, Chile. The role demands ensuring compliance in clinical studies, meeting recruitment targets, and managing clinical risks. Candidates should have a Bachelor’s degree in health care or a related field and at least 3 years of clinical research experience. Strong...

  • Senior Clinical Research Associate

    hace 7 días

    Santiago de Chile CTI Clinical Trial Services, Inc A tiempo completo

    **Senior Clinical Research Associate** (Level dependent on experience)** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can...

  • Clinical Research Associate Ii

    hace 4 días

    Santiago de Chile Labcorp A tiempo completo

    The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project...

  • Clinical Research Physician

    hace 11 horas

    Santiago de Chile Icon plc A tiempo completo

    Clinical Research Physician ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - *Recognise, exemplify and adhere to ICON's values which centres...