Data Compliance Specialist I

Work Schedule

Environmental Conditions

Job Description

TrialMed is a premier global clinical site network offering comprehensive services for clinical trials from early to late phases (Phase I to Phase IV). As a unified brand TrialMed consolidates all clinical trial offerings under one global name ensuring a seamless experience for stakeholders.

• Access to over 250 sites worldwide and a patient database of 20 million individuals ensuring robust and diverse trial enrolments.
• A patient-centric approach with capabilities for home trial services allowing patients to participate in clinical trials from their homes or communities.
• Comprehensive service offerings including early development CRO services consulting services and clinical pharmacology services.

Join TrialMed and be part of a dynamic team dedicated to advancing medical research and improving patient care through innovative clinical

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 appropriatedocumentation;assistwith 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 ; 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:

• Study management at the site level
• Maintains ISF and study trackers as delegated and verifies that ICFs are correctly completed.
• Assists with data capturing activities on one or more studies across multiple sites and regions.
• Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.
• Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.
• Assists monitors and sponsor representatives with query resolutions after monitoring visits.
• Understands 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.
• Assists in archiving procedures.
• Coordinates frequently with monitors and client representatives. Supports preparation of monitoring visit duties and clarifies any expectations relating to CRFs.
• Supports audit preparation and audit readiness.
• Identifies and escalates common data errors and trends and may assist with CAPA and problem-solving methods.
• Cooperation with Vendors

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