Senior CRA II – Site Care Partner – Sponsor Dedicated
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Job Description
Sr. CRA II responsible for site management and monitoring in clinical research for Syneos Health. Ensuring compliance with guidelines and managing site personnel as part of a global team.
Responsibilities:
- 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 Practices (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, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- At least 5-7 years of experience in clinical research monitoring and Oncology.
- 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.
- Moderate level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis.
Benefits:
- 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.
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