-
Coordinating Cra
Encontrado en: Buscojobs MX C2 - hace 2 días
Tiger Text Xico, MéxicoJob Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. · Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulator ...
-
Coordinating CRA
Encontrado en: Jooble MX O C2 - hace 2 días
IQVIA LLC Ciudad de MéxicoJob Overview · Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. · Essential Functions · • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and ...
-
Clinical Research Associate
Encontrado en: Buscojobs MX C2 - hace 2 días
Medpace, Inc. Xico, MéxicoJob Summary The Clinical Research Associate at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development. For those with medical and/or health/life science interest and background who want to explore the research ...
-
Lead Cra
Encontrado en: Buscojobs MX C2 - hace 2 días
Psc Industries Xico, Méxicoi Ad Clinical Project Manager · Clinical Project Manager · Location : CDMX · Hybrid Work ( 3 office days a week) · Role description · To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget ...
-
Clinical Research Associate
Encontrado en: Buscojobs MX C2 - hace 2 días
Astrazeneca Xico, MéxicoPrimarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level. Develops existing tools and processes to identify areas of improvement and ensures business continuity ...
-
Ctry Approval Assoc
Encontrado en: Buscojobs MX C2 - hace 1 día
Thermo Fisher Scientific Xico, MéxicoEssential Functions and Other Job Information:EssentialFunctions- Prepares, reviews and coordinates, under guidance and local EC submissions inalignment with global submission strategy.- Supports preparation, under guidance, of local MoH submissions, as applicable inalignment wit ...
-
Country Start Up Specialist
Encontrado en: Buscojobs MX C2 - hace 2 días
Medpace, Inc. Xico, MéxicoJob Summary Join Medpace in Mexico As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team, and will be mentored and su ...
-
Experienced Clinical Safety Coordinator
Encontrado en: Buscojobs MX C2 - hace 2 días
Medpace, Inc. Xico, MéxicoJob Summary Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and ...
-
Regional Clinical Research Associate Level II
Encontrado en: Jooble MX O C2 - hace 1 día
ESTERN Medical LLC MéxicoRegional Clinical Research Associate Level II & III Mexico Business Title · Regional Clinical Research Associate Level II & III · Requisition ID · EM-R-CRA-1003 · Job Category · Regional Clinical Research · Locations Job Description Job Summary: · Assures the implementation ...
-
Lead CRA
Encontrado en: Jooble MX O C2 - hace 5 días
PSC Industries Ciudad de Méxicoi Ad · Clinical Project Manager · Clinical Project Manager · Location : CDMX · Hybrid Work ( 3 office days a week) · Role description · To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, bu ...
-
Ctry Approval Assoc
Encontrado en: Talent MX C2 - hace 1 día
Thermo Fisher Scientific Mexico City, México De jornada completaEssential Functions and Other Job Information: · Essential · Functions · • Prepares, reviews and coordinates, under guidance and local EC submissions in · alignment with global submission strategy. · • Supports preparation, under guidance, of local MoH submissions, as applica ...
-
Senior Manager, Regulatory Affairs
Encontrado en: Jooble MX O C2 - hace 2 días
Worldwide Clinical Trials, LLC MéxicoWho we are · We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them wit ...
-
cra 1
Encontrado en: Talent MX C2 - hace 4 días
IQVIA Mexico City, México De jornada completaJob 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 moni ...
-
Country Approval Specialist
Encontrado en: beBee S2 MX - hace 15 horas
Thermo Fisher Scientific Ciudad de México De jornada completa· Job Description · 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 ...
Coordinating Cra - Xico, México - Tiger Text
Descripción
Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.
e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
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 / ICH 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.
Act as a mentor for clinical staff including conducting co-monitoring and training visits. Collaborate and liaise with study team members for project execution support as appropriate. If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.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. Req Requires at least 3 years of year of on-site monitoring experience. Equivalent combination of education, training and experience may be accepted in lieu of degree.In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong 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 IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
Learn more at