Clinical Research Associate

hace 4 días

Ciudad de México, Ciudad de México 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 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:
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 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

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/4/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:07/04/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R301883

  • Clinical Research Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México Healthcare Businesswomen's Association A tiempo completo

    Job Description SummaryLocation: Mexico CityAbout the role:We are seeking a Clinical Research Associate who will supply, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of...

  • Clinical Research Associate

    hace 3 semanas

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    Clinical Research AssociateCategory:Clinical DevelopmentLocation:Ciudad de México, Ciudad de México, MX- Are you ready for a life-changing career at Novo Nordisk Mexico? Join us.- Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career - you grow professionally, and you impact the lives of our patients for better....

  • Clinical Research Associate Trabajos En México

    hace 2 semanas

    Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-timeJob Overview Provides high quality, timely development and on-time input to client solutions for the pharmaceutical...

  • Operations Associate, Clinical Assessment

    hace 2 semanas

    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    Requisition Number7914**Employment Type:Regular**Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage,...

  • Clinical Research Assistant

    hace 2 semanas

    Ciudad de México, Ciudad de México COVANCE MEXICO SERVICES S DE RL DE CV A tiempo completo

    Covance is growing again in Mexico This is an exciting opportunity to join one of the fastest growing parts of our business • Act as contact for project team and study sites.• Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned...

  • Clinical Research Assistant

    hace 2 semanas

    Ciudad de México, Ciudad de México Covance Latinoamérica A tiempo completo

    Covance is growing again in Mexico This is an exciting opportunity to join one of the fastest growing parts of our business • Act as contact for project team and study sites. • Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned...

  • Clinical Research Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México Merck Gruppe - Msd Sharp & Dohme A tiempo completo

    Job Description The role is accountable for performance and compliance for assigned protocols and sites in acountry. Under the oversight of the CRA manager the person ensures compliance of study conduct withICH/GCP and country regulations, our company policies and procedures, quality standards andadverse event reporting requirements internally and...

  • Sso Expert Clinical Research Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México Novartis A tiempo completo

    Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site...

  • Clinical Research Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe 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...

  • Clinical Research Associate

    hace 1 mes

    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe 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...

  • Clinical Associate

    hace 3 semanas

    Ciudad de México, Ciudad de México ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Research Manager

    hace 1 mes

    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionOur Clinical Research and Pharmacovigilance team strives to advance global healthcare through groundbreaking research and innovation. By conducting clinical trials and surveillance, we guarantee the safety and effectiveness of our current and upcoming products, producing cutting-edge, secure, and effective medications.Essential Knowledge in...

  • Clinical Research Associate

    hace 4 semanas

    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe 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...

  • Associate Clinical Research Manager

    hace 3 semanas

    Ciudad de México, Ciudad de México 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.Primary Activities: Main Point of Contact (POC) for...

  • Clinical Research Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México 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.Knowledge in Project Management and site management:Strong...

  • Senior Clinical Research Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. 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 Centre of all that we do, we help to accelerate the development...

  • CTA - Clinical Trial Assistant

    hace 1 mes

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform 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...

  • Senior Clinical Research Associate

    hace 3 semanas

    Ciudad de México, Ciudad de México ISTITUTO MARANGONI A tiempo completo

    Company Description PSI is a leading Contract Research Organization with more than 25years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description We are looking for an experienced CRA ready to...

  • CTA - Clinical Trial Assistant

    hace 2 semanas

    Ciudad de México, Ciudad de México IQVIA LLC A tiempo completo

    CTA - Clinical Trial Assistant page is loaded CTA - Clinical Trial Assistant Apply locations Mexico City, Mexico time type Full time posted on Posted 3 Days Ago job requisition id R Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and...

  • Clinical Research Manager

    hace 1 semana

    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials andsurveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.Knowledge in Project Management and site management:Strong...