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. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
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 Pharmacoepidemiological 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.
* Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
* Assess 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 and 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.
* 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.
* Manages site‑level activities / communication to ensure project objectives, deliverables and timelines are met.
* 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.
We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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