Data compliance coordinator
Data compliance coordinator
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Data Coordinator 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. The main responsibilities are: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 ensuring an understanding of source documentation and transcription into CRF; create good relationship with customers and ensure 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; other duties as assigned e.g. named archives
Key responsibilities for a Data Compliance Coordinator are as follows:
Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.
Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.
Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.
Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.
May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.
Learns and adheres to company SOP and COP and assists with input during the review process.
Adheres to the rules and regulations of 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 multiples studies with a number of participants simultaneously
Good interpersonal skills
Excellent communication skills with Czech and English
Basic MS Office and computer skills
Ability to learn basic medical terminology
Good attention to detail
Required Experience:
IC
Employment Type
Full-Time
