- 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 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 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.
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 1 year and a half of on-site monitoring experience.
- 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.
-
Cra
hace 11 horas
Thermo Fisher Scientific Ciudad de MéxicoBachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. · Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparab ...
-
Cra
hace 2 días
Thermo Fisher Scientific Ciudad de MéxicoQualifications: · Education and Experience: · Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. · Minimal clinical monitoring experience that provides the knowledge, skil ...
-
Cra (Level I)
hace 5 días
Thermo Fisher Scientific Ciudad de MéxicoCRA (LeveI I) · Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. · Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform t ...
-
Cra (Level Ii)
hace 2 días
Thermo Fisher Scientific Ciudad de MéxicoEducation and Experience: Bachelor''s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. · Minimal clinical monitoring experience that provides the knowledge, skills, and abilities t ...
-
Cra (Level Ii)
hace 3 días
Thermo Fisher Scientific Tlahuac, MéxicoMonitors 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 dat ...
-
CRA (Level I)
hace 6 días
Thermo Fisher Scientific Mexico City, México De jornada completaEssential 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 decre ...
-
Cra (Level I)
hace 2 días
Thermo Fisher Scientific Tlahuac, MéxicoEssential 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 dec ...
-
Cra Ii
hace 2 días
ICON plc Ciudad de México**Experienced CRA - Mexico City, home-based role** · 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 ...
-
Cra I
hace 4 días
Thermo Fisher Scientific Ciudad de MéxicoPPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with u ...
-
Cra I
hace 5 días
Thermo Fisher Scientific Ciudad de MéxicoOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, wh ...
-
Ssu Cra
hace 2 días
Novartis Ciudad de MéxicoSite relationship management role to ensure sustainable trial start-up at Site. · The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence w ...
-
Cra I
hace 1 día
Fortrea Ciudad de MéxicoLabcorp Drug Development is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Research Associate I in Mexico. Rol ...
-
Cra Line Manager
hace 1 semana
Novo Nordisk Ciudad de MéxicoCRA Line Manager · **Category**:Clinical Development**Location**:Ciudad de México, Ciudad de México, MX- Are you ready for a life-changing career at Novo Nordisk Mexico? Join us.- Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career - y ...
-
Associate Cra
hace 2 días
Novasyte Tlahuac, MéxicoWhether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structur ...
-
Cra 1
hace 1 día
Novasyte Tlahuac, MéxicoJob 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 monito ...
-
In-house Cra I
hace 1 semana
Labcorp Colonia Lomas de Chapultepec, MéxicoAs 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 techn ...
-
Sr Cra
hace 1 semana
Thermo Fisher Scientific Tlahuac, MéxicoEssential 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 de ...
-
Assistant Cra
hace 1 semana
Thermo Fisher Scientific Tlahuac, MéxicoPerforms remote activities on assigned projects in liaison with the Remote CRACTM. Provides support with regards to site preparedness, logístical support to and assist with assigned tasks for site management and remote monitoring in regulatory guidelines. May be assigned limited ...
-
In-house Cra I
hace 1 semana
Labcorp Colonia Lomas de Chapultepec, México**Job Summary**: · The In-House Clinical Research Associate (IHCRA I) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the IHCRA I shall reflect their experience, and level of con ...
-
Coordinating Cra
hace 1 semana
Novasyte Tlahuac, 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 reg ...
cra 2 - Ciudad de México - IQVIA
Descripción
Job OverviewPerform 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
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
