Clinical Research Associate

🔥 13 minutes ago

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records • Applies query resolution techniques remotely and on-site • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • Supports subject/patient recruitment, retention and awareness strategies

🎯 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 • Must demonstrate good computer skills and be able to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills expected • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Health insurance • Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Flexibility in working hours