Site Care Partner I, SrCRA – FSP, Sponsor Dedicated
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Job Description
Clinical Site Partner focusing on site management and compliance with regulatory standards in a remote role. Collaborating on clinical studies with a dedicated team at Syneos Health.
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.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes.
- 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.
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.
- 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.
- We are committed to building an inclusive culture – where you can authentically be yourself.
- Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with.
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