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:
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):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 complete via review of site source documents and medical recordsApplies 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 requirementsMay 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 experienceIdeally 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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