Clinical Trial Associate

hace 5 meses

Mexico City Allucent A tiempo completo

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Clinical Trial Associate (CTA) to join our A-team (hybrid*/remote). As a Clinical Trial Associate at Allucent, you will be the primary administrative support to Allucent clinical study teams at Country/Site level, to support Clinical Trial Operations and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member at Country/Site level.

In this role your key tasks will include:

Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing. After quality check acts as Document Submitter and submits country and site level documents to eTMF Document Inbox. Resolves rejections.  Assists with resolution of periodic QC findings for country and site eTMF.  If applicable, maintains study wet-ink documents temporarily in the local office and prepares shipment to the client at the end of the study. Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.  Updates Expected Documents List (EDL) in eTMF for the country and site level. Maintains Public Folders in accordance with the Study Correspondence Management Plan Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs). Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.  Assists CRA with reconciliation of ISF/PSF vs. TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.  Assist CRAs /CTLs with query resolution and aged action item metrics follow up internally. Performs translations, back-translations or verification of translations of study documentation when needed.  Accurately updates and maintains site level CTMS, as needed.  If needed, assists the project team with CTMS reports at requested intervals to follow-up on pending entries. Contribute to other areas of business as required.

Requirements

High School Diploma/Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalence (BS/BA) preferred  Good Documentation Practices Knowledge  Good Clinical Practices Knowledge  Strong command in English language, both written and verbal. At least 1 year of experience in clinical research on CRO side is preferred Experience using eTMF, ISF/ISP is preferred. Excellent communication, organizational and listening skills Ability to confront constructively Fosters learning and the advancement and development of others Representative, outgoing and client focused Effective organizational, managerial, and time management skills Strong analytical and problem resolution skills Demonstrated ability to lead by example Demonstrated personal integrity and ethical values Demonstrated ability to see the bigger context and act appropriately Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external stakeholders Ability to work in a fast-paced challenging environment of a growing company Proficiency with various computer applications such as Word, Excel, and PowerPoint

Benefits

Benefits of working at Allucent include:

Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

  • (Senior) Clinical Trial Manager

    hace 6 meses

    Mexico City IQVIA A tiempo completo

    Clinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...

  • Clinical Trial Coordinator

    hace 3 meses

    Mexico City Thermo Fisher Scientific A tiempo completo

    Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases, an equivalency, consisting of a...

  • Clinical Research Assistant

    hace 5 meses

    Mexico City 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...

  • Clinical Research Manager

    hace 6 meses

    Mexico City MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    Description As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With...

  • Director, Head of Clinical Operations, Latam North

    hace 3 meses

    City, México Bristol-Myers Squibb A tiempo completo

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Clinical Trial Site Coordinator

    hace 6 días

    Mexico City Milestone One A tiempo completo

    Job DescriptionMilestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.In this role you will:Act as the main line of communication between the Sponsor or CRO and the site.Ensure response to feasibility questions are provided in due...

  • Clinical Research Associate II

    hace 1 mes

    Mexico City PSI CRO A tiempo completo

    Job Description As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. We are committed to develop our employees in their careers by providing tailored courses and mentoring. You will:Conduct and...

  • Senior Specialist

    hace 6 meses

    Mexico City Fortrea A tiempo completo

    The Clinical & Ancillary Supplies Services (CASS) Senior Specialist: Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. Support these services to both internal and external clients. Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies Independently...

  • Sr. Clinical Trials Assistant

    hace 5 meses

    Mexico City 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 teams...

  • Clinical Trials Senior Analyst

    hace 2 meses

    Mexico City Novo Nordisk AS A tiempo completo

    Are you passionate about clinical trials? Do you have experience ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Assistant to join our team in Mexico. If that sounds like you, read on and apply today for a life-changing career. The Position As a Clinical Trials Senior Analyst at Novo Nordisk, you...

  • Central Monitoring Associate Manager

    hace 6 meses

    Mexico City SAO Fortrea Brazil Limitada A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    hace 2 semanas

    Mexico City PSI CRO A tiempo completo

    Job DescriptionOnly CV's in English will be consideredWe are looking for a CRA to join our team in Mexico. Here you will have the opportunity to develop yourself as a senior, trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.Responsibilities will include:Preparation, conduct,...

  • Clinical Research Monitor

    hace 2 meses

    Mexico City PSI CRO A tiempo completo

    Job DescriptionAs a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. We are committed to develop our employees in their careers by providing tailored courses and mentoring. You will:Conduct and report...

  • Clinical Trials Quality Assurance Auditor

    hace 2 meses

    Mexico City PSI CRO A tiempo completo

    Job DescriptionWe are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in...

  • Cta

    hace 6 meses

    City, México ICON plc A tiempo completo

    As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will support the...

  • CRA (Level I)

    hace 5 meses

    Mexico City Thermo Fisher Scientific A tiempo completo

    Essential Functions · Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as...

  • Cta

    hace 5 meses

    City, México ICON plc A tiempo completo

    As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will support the...

  • Senior Clinical Research Associate

    hace 5 meses

    Mexico City PSI CRO A tiempo completo

    Job DescriptionWe are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.Only CVs in English will be consideredHome-based position in...

  • Senior Clinical Research Associate.

    hace 5 meses

    Mexico City PSI A tiempo completo

    Job Description We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring. Only CVs in English will be considered Home-based...

  • Centralized Monitoring Lead

    hace 6 meses

    Mexico City IQVIA A tiempo completo

    Job Overview Provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our...