Senior Clinical Research Associate

hace 1 mes


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 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 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 IQVIA A tiempo completo

    **IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support.** **Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager.** **Previous clinical trial management and CRO experience preferred.** **Therapeutic **requirements/preference**: any of the following...


  • 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...


  • 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...

  • Clinical Trial Liaison

    hace 7 horas


    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...

  • Senior QA Analyst

    hace 1 mes


    Desde casa, México Research Solutions A tiempo completo

    Join our team at Research Solutions! We are seeking a highly skilled and experienced Senior QA Analyst to join our dynamic, remote, international team. This position is** based in Mexico.** A Senior QA Analyst at Research Solutions is a flexible and capable professional with 10 years of experience in functional testing, defect tracking, test planning, and...


  • Desde casa, México Research Solutions A tiempo completo

    Join our team at Research Solutions! We are seeking a highly skilled and experienced Senior Backend Developer to join our dynamic, remote, international team. **This position is based in Mexico.** As a Senior.NET Developer you will be a key member of the backend team, playing a crucial role in our development projects. Your main responsibility will revolve...

  • Senior Cra

    hace 5 días


    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...


  • Desde casa, México Research Solutions A tiempo completo

    Join our team at Research Solutions! We are seeking a highly skilled and experienced Senior Front End Developer with experience in VueJS/React to join our dynamic, remote, international team. This position is** based in Mexico.** **Key responsibilities**: - Designing intuitive user interfaces (UI) and implementing them in our company products, leveraging...


  • Desde casa, México IQVIA A tiempo completo

    Job Overview **Please submit resumes in English** Support, with mínimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements,...


  • Desde casa, México IQVIA A tiempo completo

    Job Overview Support, with mínimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics....


  • Desde casa, México Research Solutions A tiempo completo

    As a UX Researcher, you will provide answers to the most challenging questions in our product’s design. The UX Researcher reveals what the consumers need from our products by conducting primary research, exploring consumer behavior and motivation, and working with the Product Design, Product Management, and Product Development departments in developing...


  • Desde casa, México Satellite Teams A tiempo completo

    **A highly respected and well-established LA-based personal injury firm is seeking an Associate Attorney. This firm is dedicated to personal injury representation.** **The right person for this position will have an excellent academic background with excellent multitasking and organizational skills, an ability to work with and report to others as a team,...


  • Desde casa, México IQVIA A tiempo completo

    Internal Job Description - ** Experience managing clinical trials in LATAM and North America(REQUIRED)**: - ** Strong Cardiovascular Therapeutic experience**: - **3+ years of Clinical Trial Management experience (CRO experience preferred)** **BASIC FUNCTIONS**: Responsible for the successful planning, implementation and execution of contracted clinical...

  • Senior Cra

    hace 8 horas


    Desde casa, México ICON A tiempo completo

    **Senior CRA** **Remote role** 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 set us apart as an organization:...


  • 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 IQVIA A tiempo completo

    **Job Overview** Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate...


  • Desde casa, México Research Solutions A tiempo completo

    As a senior ASP.NET / SQL developer, you will work mainly on developing and maintaining endpoints. You will also be responsible for developing, maintaining and delivering reports (SQL based) to internal customers. Daily tasks will include developing or maintaining endpoints (APIs) as well as building efficient SQL Queries. **Requirements**: At least 6...


  • 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...