Overview
Compliance specialist is an entry role within the clinical data-entry, data validation and discrepancy management. The main objective is to provide high-quality data to ensure that data are complete, reliable, and processed correctly.
Responsibilities
* Data collection and data entry to CRF; track the flow of CRFs, queries and patient recruitment status and ability to report out the flow of data.
* Set up of project files, ensuring sufficiency and accuracy of versions of appropriate documentation; assist with producing guidelines for the data entry process for studies.
* Ensure individual development and continual service improvement; be a Data Coordinator on ongoing projects to assist with the delivery of projects within timelines.
* Deliver good quality data by understanding source documentation and transcription into CRF; maintain good relationships with customers and ensure a high level of customer service.
* Work according to SOP/COPs and GCP guidelines; perform quality control as described in the relevant Synexus procedure and as applicable to the role; assist with additional duties as assigned.
* Assist with drafting compliance reports and contribute to data quality activities as required.
Key responsibilities for a Data Compliance Coordinator
* Maintains ISF and study trackers and supports verification that ICFs are correctly completed.
* Assists with data capturing activities on one or more studies and may provide support across multiple sites/regions.
* Ensures accurate and timely entry of all data into the eCRF from source notes and helps track the flow of eCRFs and queries.
* Assists with verifying protocol visit windows and reports deviations.
* May assist monitors and sponsor representatives with query resolutions after monitoring visits; escalates to management as needed.
* Adheres to company SOPs and COPs and assists with input during the review process.
* Adheres to ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
* Assists with drafting compliance reports.
Qualifications
Education and Experience
* High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
* Technical positions may require a certificate.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Knowledge, Skills and Abilities
* Ability to multi-task and support multiple studies with a number of participants simultaneously.
* Good interpersonal skills.
* Excellent communication skills with Polish and English.
* Basic MS Office and computer skills.
* Ability to learn basic medical terminology.
* Good attention to detail.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Legal, General Business, and Strategy/Planning
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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