Total 5 job vacancies by PSI CRO

The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.

The function of the role may include, but not limited to, any/all of the following:

• 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.

The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.

The function of the role may include, but not limited to, any/all of the following:

• 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.

SCOPE OF RESPONSIBILITIES

1. Communication

1.1. Serves as the communication point to project teams with regard to quality assurance (QA) study audits

1.2. Follows up with project teams with regard to resolution of PSI QA study audits

1.3. Liaises with PSI divisions/operational offices with regard to internal systems, process, and location audits

1.4. Liaises with vendors with regard to vendor qualification audits

1.5. Serves as the communication point for PSI Operations staff with regard to issues related to quality assurance

1.6. Serves as the communication point for PSI clients with regard to QA audits contracted to PSI

2. Planning and scheduling

2.1. Prepares, conducts, and reports QA study audits

2.2. Assembles QA study audits documentation

2.3. Takes part in the preparation, conduct, and reporting of internal systems audits

2.4. Takes part in the preparation, conduct, and reporting of internal locations audits

2.5. Takes part in the preparation, conduct, and reporting of vendor qualification audits

2.6. Takes part in the preparation, conduct, and reporting of internal process audits

3. Training

3.1. Trains PSI Operations staff in quality management topics

PSI CRO is looking for an experienced project finance professional in the Clinical Research industry, who will be responsible for creating, managing, negotiating, and analyzing clinical project budgets, as well as providing support with bids and contract management activities within the company.

Responsibilities:

• Development of study budget (preparation of budgets for bids and change of order budgets for on-going projects)
• Management of study budget throughout the clinical project duration (setup and maintenance of project finance information in PSI internal systems, preparation of accrual reports, request for invoices)
• Development of Sponsor Contract (preparation of sponsor agreements and change orders, development of payment schedules)
• Timesheet System Management (setup and maintenance of project-specific timesheets in PSI’s internal system, management of reconciliation of actual vs budget costs on a regular basis)

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Office location: Tokyo or Osaka 

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organise and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance