Senior Clinical Research Associate

hace 7 meses


Desde casa, México IQVIA A tiempo completo

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Qualifications**:

- Bachelor's Degree Degree in scientific discipline or health care preferred. R
- Requires at least 3 years of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.



  • Desde casa, 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 Associate

    hace 7 meses


    Desde casa, México ICON A tiempo completo

    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. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Clinical Trial Asst 2

    hace 3 días


    Desde casa, México IQVIA A tiempo completo

    Job Overview Perform 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...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...


  • Desde casa, México IQVIA A tiempo completo

    **It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.**: **Join IQVIA and see where your skills can take...


  • Desde casa, México ICON A tiempo completo

    **Clinical Data Quality Associate** **JR118136** **Site: Mexico** 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 fulfil 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...


  • Desde casa, México IQVIA A tiempo completo

    **Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF). **Essential Functions** - Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Unique Opportunity**: Join Thermo Fisher Scientific Inc. as a Trial Patient Payment Associate II in our Information Technology team. Your role will be crucial in supporting clinical trials by ensuring accurate and timely payments to participants. This is a chance to work with a...


  • Desde casa, México ICON A tiempo completo

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


  • Desde casa, México Signant Health A tiempo completo

    (This is a remote role located in Mexico) *** **Want to do the Best Work of Your Life?** Working at Signant Health puts you at the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry. We’re radically changing the clinical trial landscape, driving change through the technology and innovations we...

  • Mgr Clinical Admin

    hace 4 meses


    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: Leads the day-to-day management of multiple clinical administration team members providing direct coaching and development support to assigned staff. Oversees resourcing, alignment, training, and on-going professional development...


  • Desde casa, México IQVIA A tiempo completo

    **Based in Mexico for Sponsor Dedicated** **Job Overview** Manage a team of clinical staff working in support of clinical studies for Sponsor Dedicated model, to ensure projects are appropriately resourced and employees are trained and meeting project objectives. **Essential Functions** - Manage staff in accordance with organization’s policies and...


  • Desde casa, México IQVIA A tiempo completo

    Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing...


  • Desde casa, México IQVIA A tiempo completo

    projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining...


  • Desde casa, México Parexel A tiempo completo

    Mexico, Remote **Job ID** R0000028052 **Category** Data Management **ABOUT THIS ROLE**: Key Accountabilities: - Data Validation: Lead data cleaning, review, and reconciliation activities. - Documentation: Prepare and maintain DM documents as per SOPs and guidelines. - Study Start-Up: Conduct UAT on clinical database setups and review protocols. Quality...


  • Desde casa, México Mindtech A tiempo completo

    **UX Research Support Associate** Mindtech is your gateway to exciting and impactful tech projects. We specialize in end-to-end software outsourcing, linking Latin American talent with global opportunities. Our fast, cost-effective approach ensures that our clients receive exceptional service and innovative solutions. With a diverse team of over 70 skilled...


  • Desde casa, México IQVIA A tiempo completo

    **Sr Clinical Trials Assistant** **Location**: Mexico City - Hybrid role Job Overview Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies. Provides project-related support to the project management...