CRA II- Birmingham, AL- Oncology- Sponsor DedicatedUpdated: November 7, 2024
Location: United States-North America - USA-Alabama-Home-Based
Job ID:24006073
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Job Responsibilities
• 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.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and completeApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessaryUtilizes available hardware and software to support the effective conduct of the clinical study data review and captureVerifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.Qualifications
• 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
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
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