Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 enrollments.
* 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 trials.
Position: Compliance Specialist
This entry role involves clinical data-entry, data validation, and discrepancy management. The main objective is to provide high-quality data that is complete, reliable, and processed correctly. Key responsibilities include:
* Data collection and data entry to CRF; tracking flow of CRFs, queries, and patient recruitment status; reporting on data flow.
* Setting up project files, ensuring the accuracy of documentation versions.
* Assisting in producing guidelines for data entry processes.
* Supporting individual project delivery within timelines as a Data Coordinator.
* Ensuring data quality by understanding source documentation and transcription into CRF.
* Building good relationships with customers and providing high-level customer service.
* Working according to SOPs, COPs, and GCP guidelines.
* Performing quality control as per relevant procedures.
* Other duties as assigned, such as managing archives.
Key Responsibilities:
* Maintaining ISF and study trackers, supporting ICF verification.
* Supporting data capturing activities across studies and sites.
* Ensuring accurate and timely data entry in eCRF from source notes.
* Verifying protocol visit windows and reporting deviations.
* Assisting with query resolution and escalating issues when necessary.
* Adhering to company SOPs, COPs, and regulatory guidelines.
* Drafting compliance reports.
Qualifications:
Education and Experience:
* High/Secondary school diploma or equivalent with relevant qualifications.
* Technical positions may require a certificate.
* At least 2 years of relevant experience.
Knowledge, Skills, and Abilities:
* Ability to multitask across multiple studies.
* Good interpersonal skills.
* Excellent communication skills in Polish and English.
* Basic MS Office and computer skills.
* Ability to learn medical terminology.
* Strong attention to detail.
#J-18808-Ljbffr