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 sitespecific 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 :
This job is for you if youre independent natural problemsolver and deeply passionate about assisting health care communities in delivering lifechanging treatments to patients. You must have a college or university degree in Life Sciences and minimum 2 years of experience in as a Study Coordinator on site.
Flexibility in working hours and sites may be required depending on the schedule of study procedures and/or patient visits.
Additional Information :
We value your time so the recruitment process is short and remote to the extent possible. Only one face to face meeting is required to actually get to know each other.
Our recruitment process includes:
- Analysis of applications
- HR interview remote around 30 minutes high level discussion of your experience expectations of the role and command of English (youll work in Polish on the site but we are an international company and youll need to speak English to have development opportunities)
- Operations interview f2f in Warsaw with an Operations team member (Site Lead and/or Sites Manager) around 1 hour this is a more detailed discussion to check your practical knowledge of trial management on the site and provide you with all additional information you may still need after the 1st stage
- Presenting the offer and signing the agreement this can be done 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.
Remote Work :
No
Employment Type :
Fulltime