Clinical Research Associate II / Senior CRA – Full Service

November 21

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔬 Research Analyst

🦅 H1B Visa Sponsor

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Syneos Health

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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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Performs site qualification, site initiation, interim monitoring, site management activities 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. • Assesses site processes and 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. • Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. • 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. • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP is dispensed and administered to subjects/patients according to the protocol. • Routine reviews of the Investigator Site File (ISF) for accuracy, timeliness and completeness. • 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 • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • flexible paid time off (PTO) and sick time • potential company car or car allowance • bonuses based on company and individual performance