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Job Details

CRAII/SCRA Poland

Company: Syneos Health
Location:
Reference: CRAI/CRAII/SCRA - 18006069
Closing Date: 07 Oct 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Here at Syneos Health we are currently recruiting for a CRA or SCRA to work for one the world’s leading Pharmaceutical companies

Requirements:

CRA II/SCRA (Poland)

Poland

Office-based or home based

Permanent contract

 

Job Details:

 

Main responsibilities include but are not limited to:

  • Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
  • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
  • Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
  • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
  • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
  • Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
  • Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types.
  • Prepares trial sites for close out, conduct final close out visit.
  • Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
  • Negotiates investigator budgets at site level, if applicable.

 

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

 

  • BA/BS degree is required. A degree in a health or science related field is preferred.
  • At least 2 years of clinical trial monitoring experience is preferred.
  • Proficient in speaking and writing the country language and English. Good written and oral communication skills.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems.

 

 

We have a comprehensive benefits package and offer highly competitive remuneration.


If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

 

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

 

#LI-MB1

 

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Apply for this job: CRAII/SCRA Poland

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

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