Clinical Research Associate

hace 4 días

Colombia Fortrea Inc. A tiempo completo
Sr Centralized Study Associate

Fortrea Inc. is seeking a highly skilled and detail-oriented Sr Centralized Study Associate to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical systems and access, maintaining study databases, and supporting the study team in data review and other related activities.

Key Responsibilities:
  • Clinical Systems & Access Management:
    • Manage clinical systems and access to ensure seamless data flow and compliance.
    • Maintain study databases, including CTMS, IWRS, EDC, and other relevant systems.
    • Support the study team in data review and other related activities, ensuring high-quality data and timely delivery.
    • Track and follow up with CRAs for outstanding issues and action items.
    • Generate study-specific reports to facilitate decision-making and progress tracking.
    • Manage internal and external communications to ensure effective collaboration and information sharing.
  • Data Review:
    • Follow up with CRAs for resolution of outstanding issues and action items.
    • Assist the Lead with study-specific data review tasks, ensuring accuracy and completeness.
    • Draft and send study-specific reports to stakeholders, highlighting key findings and recommendations.
    • Perform other data review-related tasks as instructed by the project team, ensuring high-quality deliverables.
  • Document Review:
    • Review Initial and Amended Investigator Packages for regulatory compliance, ensuring adherence to ICH-GCP guidelines.
    • Review Amended Country/Site Informed Consent Forms, ensuring accuracy and completeness.
    • Filing amended Informed Consent Forms and Investigator Package approval documentation in TMF and eTMF, maintaining a secure and compliant record.
    • Review Investigator Package Plans as per SOP, ensuring alignment with company policies and procedures.
  • Study Support:
    • Generate study reports and perform analysis to facilitate decision-making and progress tracking.
    • Manage access on applicable study systems, ensuring seamless data flow and compliance.
    • Set up study systems for new awarded studies, ensuring timely and accurate setup.
    • Ensure CTMS compliance, maintaining accurate and up-to-date records.
    • Manage project communications, ensuring effective collaboration and information sharing.
  • Investigator Payments:
    • Review EDC, contracts, and marking line items for payment, ensuring accuracy and completeness.
    • Coordinate payment batch generation in CTMS, ensuring timely and accurate payment processing.
    • Perform invoice QC and prepare GIA as applicable, ensuring compliance and accuracy.
    • Coordinate with CTL and PM for approvals, ensuring seamless payment processing.
    • Process Out of Pocket and Pass-Through Expense Invoices, ensuring timely and accurate payment processing.
    • Perform payment reconciliation, ensuring accuracy and completeness.
  • General Responsibilities:
    • Follow all applicable departmental SOPs and Work Instructions, ensuring compliance and accuracy.
    • Complete required trainings within specified timelines, ensuring up-to-date knowledge and skills.
    • Ensure quality and productivity in day-to-day tasks, maintaining high standards and expectations.
    • Manage project and technical documentation appropriately, ensuring secure and compliant storage.
    • Provide administrative and technical support to internal departments, ensuring effective collaboration and information sharing.
    • Ensure quality checks of completed work, maintaining high standards and expectations.
    • Ensure timely escalation and issue resolution, maintaining a proactive and responsive approach.
    • Track and report metrics as determined by management, ensuring accurate and timely reporting.
    • Participate in process improvement opportunities, ensuring continuous learning and growth.
    • Assist in document management and preparation of new investigator submission packages, ensuring accurate and timely delivery.
    • Support study start-up activities and site clinical trial contracts management, ensuring seamless and compliant setup.

Qualifications:

  • University/College Degree (Life Science preferred) or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or laboratory technology).
  • 3-5 years of work experience in clinical research, with a strong working knowledge of ICH-GCP guidelines and all other applicable guidelines and regulations.
  • Relevant and equivalent experience may be considered in lieu of educational requirements.

Experience:

  • 1-2 years in relevant experience to this role.
  • Demonstrated ability to organize and communicate effectively.
  • Attention to detail and high-quality work delivery.
  • Ability to work well with others and use computer and departmental tools effectively.

Fortrea Inc. is an Equal Opportunity Employer, committed to diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on the needs of our business and the qualifications of the individual.

  • Clinical Research Associate Director

    hace 7 días

    Colombia ICON A tiempo completo

    About the Role:We are seeking a highly experienced and skilled Clinical Research Associate to join our team at ICON. As a Principal CRA, you will be responsible for the conduct and management of clinical trials, ensuring the highest level of quality and compliance.Key Responsibilities:Manage and maintain timelines, ensuring accuracy and completeness of data...

  • Clinical Research Associate Director

    hace 3 semanas

    Colombia ICON A tiempo completo

    Job SummaryWe are seeking a highly experienced and skilled Clinical Research Associate to join our team at ICON. As a Principal CRA, you will be responsible for the conduct and management of clinical trials, ensuring the highest level of quality and compliance.Key ResponsibilitiesManage and maintain timelines, ensuring accuracy and completeness of data...

  • Clinical Research Associate Lead

    hace 3 semanas

    Colombia ENGINEERINGUK A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced Clinical Research Associate Lead to join our team. As a key member of our clinical research organization, you will be responsible for managing and coordinating clinical trials, ensuring timely and accurate data collection, and providing guidance and support to junior staff.Key ResponsibilitiesManage...

  • Clinical Research Associate

    hace 3 semanas

    Colombia Fortrea Inc. A tiempo completo

    Sr Centralized Study AssociateFortrea Inc. is seeking a highly skilled and detail-oriented Sr Centralized Study Associate to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical systems and access, maintaining study databases, and supporting the study team in data review and other related...

  • Clinical Research Manager

    hace 4 días

    Colombia ENGINEERINGUK A tiempo completo

    Job Title: Clinical Trial ManagerAs a Clinical Trial Manager at ENGINEERINGUK, you will be part of a global clinical research organization that is powered by healthcare intelligence. You will be working with a pharmaceutical company that is committed to discovering and developing treatments that improve and save people's lives.Key Responsibilities:Plan,...

  • Sr Cra I with Oncology Experience

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Research Associate I with oncology experience - Home Based Colombia** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Sr Cra I- Colombia

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

  • Research Associate, Medellín, Colombia

    hace 4 meses

    Colombia Innovations for Poverty Action A tiempo completo

    **Summary**: Innovations for Poverty Action (IPA) seeks a Research Associate based in Medellín, Colombia, to support a portfolio of research projects on organized crime led by Christopher Blattman (The University of Chicago), Benjamin Lessing (The University of Chicago), Arantxa Rodríguez (Princeton University) and Santiago Tobón (Universidad EAFIT). This...

  • Cra Ii- Colombia Client Based Bogota/ Medelin

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...

  • Cra All Levels Bogota- Colombia

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II or SR CRA - Colombia Client Based** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Come discover what our...

  • Cra Ii or Sr Cra Bogota- Colombia

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II or SR CRA - Colombia Client Based** **Bogota** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career...

  • Senior Research Associate, Medellín, Colombia

    hace 4 meses

    Colombia Innovations for Poverty Action A tiempo completo

    **Summary**: Innovations for Poverty Action (IPA) seeks a Senior Research Associate based in Medellín, Colombia, to support a portfolio of research projects on organized crime led by Christopher Blattman (The University of Chicago), Benjamin Lessing (The University of Chicago), Arantxa Rodríguez (Princeton University) and Santiago Tobón (Universidad...

  • Senior Clinical Trial Manager

    hace 2 semanas

    Colombia ICON A tiempo completo

    Job Title: Senior Clinical Trial ManagerICON 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.Job Summary:We are currently seeking a Senior Clinical Trial...

  • Senior Clinical Trial Manager

    hace 2 semanas

    Colombia ICON A tiempo completo

    Clinical Trial Manager II - Mexico, Colombia, Brazil, Chile, Peru 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. We are currently seeking a...

  • Associate Clinical Account Specialist

    hace 4 meses

    Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are crucial to continue building our history of groundbreaking and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...

  • Regulatory Consultant with Clinical Trial Experience

    hace 4 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **JOB TITLE: Regulatory Consultant** **JOB CODE: SH1837** **BUSINESS TITLE: Regulatory Consultant** **BUSINESS UNIT: Global Regulatory Affairs Solutions (GRAS)** **REPORTS TO: Director/Associate Director/Manager, GRAS or designee** **JOB SUMMARY** Provide regulatory and technical support for assigned product development projects,...

  • Field Clinical Specialist Medsurge

    hace 4 meses

    Colombia Boston Scientific Corporation A tiempo completo

    **Field Clinical Specialist Medsurge - Barranquilla**: - Work mode: Field Based- Onsite Location(s): Bogota, CUN, CO**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...

  • Clinical Data Reviewer

    hace 4 meses

    Colombia, Huila ICON A tiempo completo

    As a Clinical Date Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites - Perform ongoing...

  • Senior Clinical Trial Manager, Oncology, Colombia

    hace 4 meses

    Colombia Novasyte A tiempo completo

    Required: 3+ years of Clinical Trial Management experience (CRO experience preferred). Experience managing clinical trials in LATAM and North America required Oncology experience related to managing studies Fluent in English, both writing and verbally Preferred: Experience managing global studies Experience managing studies in other therapeutic areas...

  • Associate Clinical Specialist

    hace 4 meses

    Colombia Medtronic A tiempo completo

    **Careers that Change Lives** A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. **A Day in the Life **Responsibilities may include the following and other duties may be assigned. - Conducts on-site education and...