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Job Details

Clinical Monitoring Associate / CRA, Sweden

Company: Syneos Health
Location:
Reference: 00007
Closing Date: 05 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

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.

Requirements:

We are currently seeking an experienced CRA to join our company, Syneos Health, and be office-based or home-based across Sweden. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting studies of a well-known and established pharmaceutical company.
The Clinical Research Associate performs routine site visits to ensure that the rights and well being of human subjects are protected. Additionally, the Clinical Research Associate assists in training and mentoring other regional monitoring personnel. In doing this, the Clinical Research Associate represents Syneos Health and the sponsor to site personnel and colleagues with professionalism and integrity.
This position requires monitoring visits to sites. Candidates with a varied therapeutic area background are encouraged to apply.

 

Responsibilities:

  • Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits,
    to include monitoring of proper informed consent procedures, compliance with
    protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and
    assurance of good site performance.
  • Document each visit with a quality written monitoring visit report and submit to the
    reviewer for review and approval within contractual guidelines
  • Author and send follow up letter to investigative site documenting the visit and any
    outstanding items to be addressed within contractual timelines.
  • Review and approve monitoring visit reports ensuring finalization within contractual
    obligations.
  • Assist Project Managers in study execution by acting as Lead CRA on projects and
    facilitating communication with Clinical Monitoring team.
  • Perform monitoring evaluation visits with CRAs.
  • Develop and facilitate training for colleagues on clinical, regulatory, administrative, and
    company procedures and processes.
  • Develop study specific tools for tracking and reporting for Clinical Monitoring team.
  • Participate in feasibility studies.
  • Develop and write Clinical Monitoring Plans.
  • Present study materials at Investigator/study launch meetings when required.
  • Support project management team with assessment of workload and site assignments
    within the project team.
  • Assist project management team with review of monitoring reports and study documents when required.
  • Participate in company-required training programs.
  • Participate on BID defense meeting.
  • Perform necessary administrative functions (e.g. submission of expense reports, entering time).
  • Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution.
  • Perform regulatory activities, if applicable.

 

 

Eligibility/Qualifications/Requirements

  • Extensive clinical monitoring experience 
  • Extensive knowledge of Good Clinical Practice/ICH Guidelines and other applicable
    regulatory requirements
  • Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus
  • Proven ability to work independently in a fast-paced environment
  • Strong communication, interpersonal, and organizational skills. Mentoring capabilities
  • Must demonstrate good computer skills
  • Ability to provide clear direction and guidance to others
  • Position requires approximately 60% travel (up to 80% during peak times)
  • Fluency in Swedish and a high level of English language are required

 

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 or contact Yana Como on +49 (0)6102 813 190 or yana.como@syneoshealth.com.

 

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

 

Apply for this job: Clinical Monitoring Associate / CRA, Sweden

Contact Information:

Address:  inVentiv Health UK Ltd
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
SL6 7AA, UK
England
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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