Single Sponsor Sr CRA I - Monitoring Ireland sites only. Must have experience in Neurology, and/or Immuno-Inflammation (Respiratory/Dermatology), and/or Rare Disease, and/or Vaccines.
Updated: December 31, 2024
Location: Ireland-Europe - IRL-Home-Based
Job ID:24007087
Single Sponsor Senior Clinical Research Associate I - Ireland only.
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.
Job 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 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.
* Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. 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):
o Assesses site processes
o Conducts Source Document Review of appropriate site source documents and medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary
o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
o Verifies site compliance with electronic data capture requirements
* May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
* Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
* 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.
* Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
* May act as primary liaison with project 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.
* May provide training or mentorship to more junior level CRAs.
Qualifications
What we’re looking for
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
* Ideally an experienced CRA with UK on-site monitoring experience gained from a CRO/Pharma.
* Must demonstrate good computer skills and be able to embrace new technologies.
* Excellent communication, presentation and interpersonal skills.
* Phase I - III studies. Must have Neurology, and/or Immuno-Inflammation (Respiratory/Dermatology), and/or Rare Disease, and/or Vaccines.
* Ireland sites only.
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