Senior Clinical Research Associate II – Nordics (Remote)

1105 Syneos Health Clinical Research Services, LLC

Denmark

Remote

DKK 486,000 - 673,000

Full time

14 days+

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Job summary

Syneos Health is seeking a Sr CRA/CRA II (Nordics) with homebased flexibility in Norway, Finland, Denmark and Sweden. You will perform site qualification, initiation, monitoring and close-out visits, on-site or remotely, ensuring GCP/ICH compliance and protocol adherence.

Applicants should have a bachelor’s degree or RN, strong communication skills and the ability to travel up to 75%. Knowledge of ICH/GCP guidelines and computer proficiency are essential for success in this role.

Qualifications

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Must demonstrate good computer skills and be able to embrace new technologies.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
Uses judgment to evaluate site performance and provide recommendations; communicates issues to the project team and develops action plans.
Maintains knowledge of ICH/GCP and relevant regulations; follows SOPs/processes.
Verifies informed consent processes and confidentiality.
Assesses safety and data integrity factors at investigator sites.
Supports site recruitment, retention and awareness strategies.
Enters data and tracks observations and action items to resolution.
Ensures IP handling and accountability per protocol.
Trains site personnel on requirements and participates in investigator meetings.