Job Title: CRA II - Sponsor-dedicated
Job Location: Leeds, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Description
Clinical Research Associate II - Sponsor-dedicated
Immunology And Rare Disease Experience Will Be Asset
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.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
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.
* Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records.
* 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.
* Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
* Verifies site compliance with electronic data capture requirements.
* 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.
* 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.
* Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
* Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
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.
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