Data Compliance Specialist

Work Schedule

Environmental Conditions

Job Description

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. 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 Polish and English

• Basic MS Office and computer skills

• Ability to learn basic medical terminology

• Good attention to detail