(Sr) CRA - Sweden, Sponsor-dedicated

Employer
Syneos Health
Location
Sweden (SE)
Salary
negotiable
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
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(Sr) CRA (Sweden) 

Office-based or home-based

Permanent contract

Sponsor-dedicated

Job Details:

As (Sr) CRA your main duties will include, but will not be limited to:

  • Ensure for Country trial start up activities, i.e. Translation of study documents, HA submission and Clinical supplies check-up/import at project level.
  • Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
  • Support the site initiation and training executed by CRAs.
  • Ensure Country Specific master file and facilitate preparation and monitor the collection of site Level documents by CRAs; resolve problems as required.
  • Ensure Planning and Set up the local trial timeline with CRA for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities.
  • Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
  • Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary.
  • Liaise with global TA/BU clinical teams and CPOs to identify issues and mediate resolution in a timely manner at a project level.
  • Review study monitoring reports which monitor generated, as assigned.
  • Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the GMO Head for information and/or resolution in a timely manner.
  • Supervise the monitor of the implementation of site closeout activities.
  • Act as local and/or global CRA lead and author global monitoring plan, as assigned.
  • Act as a mentor to new associates for purposes of field training, as assigned.
  • Work to coordinate for audits if necessary.
  • Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.

 Eligibility/Qualifications/Requirements

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

 

 

  • Education: A degree in scientific or health discipline required and advanced degree is preferable
  • Fluent English (both written and spoken)
  • Understand and apply medical and business know-ledge to clinical trial execution.
  • About 2 years’ experience in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
  • Oncology experience will be asset.
  • Solid understanding of clinical trial design, trial ex-ecution and operations.
  • Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
  • Expertise in communication, managing multiple priorities and computer literacy.
  • Proven people management skills with demonstrated expertise in working on teams.

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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