Clinical Trials Site Coordinator
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Milestone 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 time.
- Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
- Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
- Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
- Maintain study specific and general tracking of documents at the site level.
- Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
- Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
- Proper handling accountability and reconciliation of investigational products and clinical supplies.
- Collect handle and maintain all site-specific regulatory documents as needed.
- Facilitate and support the contract and budget negotiations at the site level.
- Support Investigator and Site payments and processes as needed.
- Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
- Prepare for and participate in onsite study audits or regulatory agency inspections.
- Build and sustain long-lasting relationships with existing and potential clients (sponsors CROs medical institutions).
Qualifications :
- College or university degree in Life Science preferably in pharmacy nursing or lab analytics.
- Minimum of 2 years of on-the-job experience in a clinical trial environment where relevant experience has been gained in clinical trials clinical terminology and medical research working in the role of a Study Coordinator or similar function.
- Upper-intermediate level of English with the ability to work in a global team environment.
- Experience in Oncology Renal or Cardiology clinical studies is a plus.
- Ability to work in a fast-paced environment with short timelines and multiple tasks to be completed simultaneously.
- Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
- Strong interest in professional growth and development within the company.
Additional Information :
If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people then Milestone One is the right choice for you.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Experience Working With Students
- Google Docs
- Organizational skills
- Classroom Experience
- Data Collection
- Materials Handling
- Workers' Compensation Law
- OSHA
- Special Operations
- Team Management
- Experience with Children
- Supervising Experience
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
