Single Sponsor Sr CRA I - Anywhere in the UK. Must have UK monitoring experience. Oncology and autoimmune diseases.
Updated: December 31, 2024
Location: United Kingdom-Europe - GBR-Home-Based
Job ID:24006874
Single Sponsor Senior Clinical Research Associate I
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.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
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.
* 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):
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 Verifies site compliance with electronic data capture requirements.
* May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
* 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.
* 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
* An experienced CRA with UK monitoring experience gained from a CRO, or Pharma company.
* Must demonstrate good computer skills and be able to embrace new technologies.
* Excellent communication, presentation and interpersonal skills.
* UK wide travel.
* Experience in phase II/III studies - oncology and autoimmune diseases.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.
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