Clinical Site Coordinator
Clinical Site Coordinator
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Job Description
FIDELIS RESEARCH is a Life Science Service Company part of BioIVT a leading global provider of research models and valueadded research services for drug discovery and development. We specialize in control and diseasestate biospecimens including human tissues cell products blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples.
Now we are looking for a new colleague for the role ofClinical Site Coordinatorin Bucharest Romania.
Main Responsibilities:
- Project support collation of clinical reports data entry in electronic systems collection sites visits as needed
- Daily update trackers with both shipments details and clinical data
- Gain competence related to the assigned clinical trial protocols
- Prepares transport documents and AWBs for all collected cases later saving them in the project folder communication with Sponsors
- Provides technical support organizes monthly transport of samples from the country to the assigned destination identifies the cases talks with the transport company to schedule the transport creates the shipping manifest checks it makes sure to get the transport supplies (dry ice LN2 special box etc.
- Responds to laboratorys requests regarding these monthly shipments/concerns/misunderstandings.
- Assistance in preparation of project materials (study tracking filing etc.
- Assistance for tissue procurement to the sites according to GCP SOPs and regulatory requirements
- Assistance in conducting site feasibility and assessment
- Assistance in submitting documents to Ministry of Health Executive Agency for Transplantation hospital Local/National Ethics Committees
- Multichannel communication with Hospital Personnel Sponsors Monitors Couriers and with other possible thirdparty entities
- Preparation of standard operating procedures
- Evaluate potential problems and technical hitches and develop solutions
- Communicate withsite/hospital staff to identify and define project requirements scope and objectives.
- Supervise current projects and active communicate with all team members to keep workflow on track
- Assistance with general office administrative nd operational work (keep registries maintain time sheet other reports and trackers schedule meetings organizing venues for trainings)
Requirements:
- University degree in Biotechnology Medical Engineering Pharmacy Biochemistry and/or Biotechnology etc;
- At least 13 experience years in medical field or related domains: biochemistry medical devices engineering medical services and/or medical consumables biotechnology clinical data operators etc;
Will be considered as a great advantage:
- High level of MS Excel knowledge;
- Medium/High level of English;
- Experience in using and uploading clinical data to medical platforms;
- Excellent communication and organization skills
- Ability to perform multitasking;
- Organization skills and attention to details;
- Ability to work independently.
What to expect if you join us:
- Career opportunity in a developing company with international exposure;
- Work with a team of professionals;
- Excellent working conditions;
- Competitive remuneration package.
All applications will be treated in strictest confidentiality. Only shortlisted candidates will be contacted.
Required Experience:
IC
Employment Type
Full-Time
