Clinical Site Coordinator / Studienkoordinator at PSI CRO

Kassel, Hesse, Germany -

Full Time

Start Date

Immediate

Expiry Date

28 Jun, 26

Salary

0.0

Posted On

30 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ICH-GCP, Clinical Trial Activities, Feasibility Questions, Monitoring Visits, Patient Enrollment, Data Entry, EDC Systems, Adverse Events Reporting, Protocol Deviations Reporting, Investigational Products Handling, Regulatory Documents Management, Contract Negotiation, Budget Negotiation, Study Procedures, Audits Preparation, Inspections Preparation

Industry

Pharmaceutical Manufacturing

Description

Company Description Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description 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. Qualifications Completed vocational training as a nurse ("Gesundheits- und Krankenpfleger/in" or "Pflegefachfrau/Pflegefachmann") or Medical Assistant ("MFA" = "Medizinische Fachangestellte"), or completed degree in a relevant field (e.g. health sciences, biology, pharmacy, public health) Minimum of 2 years of on-the-job experience as a site coordinator 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. Valid IATA and GCP Certification Fluent English and German Additional Information It's a hybrid part time position 0.75 FTE. 30h per week. 20h On site, 10h remotely. 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.

Responsibilities

The Site Coordinator supports clinical trial activities at a study site, adhering to ICH-GCP and protocol requirements to meet timelines and enrollment goals. Key functions include acting as the main communication line between the Sponsor/CRO and the site, managing monitoring visits, tracking enrollment, and ensuring accurate data entry and timely reporting.