Clinical Research Associate II

4 weeks ago


Linköping, Östergötland, Sweden Pharmiweb Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
Requirements
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
About Us

At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.


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