Líder de Coordinadores de Estudios de - Zapopan, México - EtCurae

EtCurae

Empresa verificada

Zapopan, México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

EtCurae is growing Are you interested in developing your knowledge and participating in high-impact clinical research? This vacancy is for you.

EtCurae, has the genuine purpose of saving lives through the development of projects and protocols with Sponsors and Clinical Research of increasingly safer and better medicines for patients.

For expansion, we are looking for talent.

EtCurae in Clinical Drug Research offers comprehensive solutions with a genuine focus on quality, efficacy and ethics to save more and more lives.

At EtCurae we are committed to respecting each person, so we do not accept any type of discrimination. And we maintain an open-door policy for diversity and inclusion.

Our success depends on our culture focused on improving the quality of life of our patients through the synergy of our professionals aligned in the values of leadership, excellence, integrity and diversity.

Vacancy profile:

Vacant position:
Study Coordinator Leader (Clinical Research)

Workplace:

CDMX, (it is essential that you reside in CDMX, with availability to move to different sites in CDMX, metropolitan area, State of Mexico and Querétaro).

Required studies:
Ing QFB, QFI / Lic in medicine or career to end to health sciences.

Experience:

minimum 5 years verifiable leading work teams in clinical research sites / projects of clinical research protocols in pharmaceutical or CROs or SMOs.

Required competences:

Expertise:
Expert in Clinical Research / Clinical Trials protocols, at site level (hospital, clinic, research organizations). It requires extensive knowledge in Good Clinical Practices (ICH-GCP), as well as in national and international clinical research regulations.

Availability:
with availability of schedule for full working day from Monday to Friday.

Job
Objective:

Lead, ensure and control that clinical research studies are complied with according to the protocol and the applicable national and international regulations in a timely manner for the successful activation of research sites.

Main responsibilities of the position:

Direct, plan, organize and control the processes, procedures and activities related to the generation, collection and documentation of all essential documents of clinical studies executed on the site.
Ensure the correct handling of the documents generated during the execution of clinical trials, among all study personnel.
Supervises and verifies the submission of the required documentation of a clinical trial to the Research Ethics Committee, Research Committee and/or Biosafety Committee, as appropriate.
Supervise and verify the submission of the required documentation of a clinical trial to the Sponsor or the Regulatory Agency (COFEPRIS).
Coordinate with the different areas of the research site and the study staff, to obtain the information and documentation for its timely and complete inclusion in the Master Folder of the clinical study.
Supervise and verify the transcription of Case Report Forms (CRFs), as well as the resolution of inquiries and discrepancies.
Supervise and ensure with the principal investigator an adequate report of all adverse events extracted from the study and communicate it to the sponsor, Research Ethics Committee, Research Committee and the corresponding regulatory agencies in the times established in SOPs, protocol and local regulation on the timing of the reports.
Supervise and control the correct use of supplies, materials and equipment for the conduct of the clinical study of the research sites.
Responsible for receiving and guiding QA, study monitors, sponsors, Research Ethics Committee and Research Committee and audits of regulatory agencies.
Plan with the responsible pharmacy the activities of the pharmacy.
Verify and ensure calibration and carry out activities for verification of proper functioning of equipment/instruments with relevant site authorities or departments.
Supervise, advise and support that the research site carries out the activities in order to achieve compliance with the requirements of the sponsors and regulatory authorities, through the implementation of actions derived from the observations given during the audit.
Supervise and control any deviation during the conduct of the study, ensuring adequate reporting, management and closure, as well as monitoring the plan of corrective-preventive actions.
Attend meetings of researchers and / or meetings derived from the clinical research project of the corresponding sites.
Support in the conduct of study feasibilities.
Support in any activity related to its activities by the Head of Department.

Offer:

Salary according to verifiable experience, since $30,000.00 until $50,000.00 net

Benefits under the law

Excellent working environment

Dynamic environment

Job stability

If you meet the required profile, please send us your updated CV by this means

Tipo de puesto:
Tiempo