Emmes Biopharma Global, s.r.o., a full service clinical research organization (CRO) is seeking Clinical Research Associate.

The key responsibilities of a Clinical Research Associate are the following:

• Evaluates, initiates, monitors and closes out clinical study site

• Ensures clinical study compliance with Good Clinical Practice (GCP), applicable regulations and SOPs

• Responses to site-related queries and escalates site-related issues

• Ensures adherence to timelines

• Conducts sites feasibility, selection, initiation, monitoring and close-out visits and prepares reports from these visits for Clinical Operations Manager approval

• Assists in planning, executing, and reporting on clinical trials

• Assists in the preparation of study-related documentation including clinical trial timelines, recruitment plans and ICF

• Builds and maintains solid professional relationship with investigators and site staff

• Identifies site needs and site-related issues, escalates them and/or initiates corrective actions when necessary

• Ensures appropriate safety reporting as well as tracking and reporting of adverse events

• Verifies case report forms against source documentation

• Coordinates supply delivery/retrieval of clinical trial supplies and investigational product/medical device from/to sites

• Performs investigational product/ medical device accountability and reconciliation. Maintains site’s study supplies.

• Facilitates the resolution of study queries to site staff

• Cooperates in submission of applications/notifications to IRB/IECs and/or Regulatory Authority

• Ensures clinical study sites are conducting the studies in compliance with the respective Protocol/Clinical Investigation Plan, SOPs, GCP and other applicable regulations

Minimum Education & Experience

· B.Sc. (Life Sciences or related field) or a qualified nurse or life science experience in a pharmaceutical or biotechnology company, a CRO, or other relevant clinical setting

· Fluent in English, both written and verbal.

Employment Type

· Preferably Part-time or Freelancer

Interested candidates should submit a CV and cover letter in English to: jobs@emmes.com