Clinical Research Study Coordinator Leader
hace 1 semana
EtCurae is a clinical research organization dedicated to improving the quality of life of patients through the development of innovative projects and protocols. We are committed to respecting each person and maintaining an open-door policy for diversity and inclusion.
Job SummaryWe are seeking a highly experienced Study Coordinator Leader to join our team. The successful candidate will be responsible for leading, ensuring, and controlling that clinical research studies are conducted in accordance with the protocol and applicable national and international regulations.
Key Responsibilities- 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 documents generated during the execution of clinical trials, among all study personnel.
- Supervise and verify the submission of 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 required documentation of a clinical trial to the Sponsor or the Regulatory Agency (COFEPRIS).
- Coordinate with different areas of the research site and study staff to obtain information and documentation for 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 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.
- Minimum 5 years verifiable leading work teams in clinical research sites/projects of clinical research protocols in pharmaceutical or CROs or SMOs.
- Expertise in Clinical Research/Clinical Trials protocols, at site level (hospital, clinic, research organizations).
- Extensive knowledge in Good Clinical Practices (ICH-GCP), as well as in national and international clinical research regulations.
- Availability of schedule for full working day from Monday to Friday.
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
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