Clinical Data Coordinator

Job Summary
We are seeking a highly organized and detail-oriented Clinical Data Coordinator to support the successful management of clinical trials and research projects. The ideal candidate will possess a strong background in clinical data management, clinical trials processes, and regulatory compliance. As a key member of our research team, you will oversee data collection, ensure data integrity, and facilitate accurate documentation review to support the development of new therapies and medical advancements. This paid position offers an exciting opportunity to contribute to cutting-edge clinical research in a collaborative environment.

Duties

• Coordinate and manage data collection processes across multiple clinical trials, ensuring accuracy and completeness.
• Review and verify study documentation for compliance with regulatory standards such as FDA regulations, ICH GCP guidelines, and HIPAA requirements.
• Monitor patient data, including vital signs, blood sampling, and other clinical measurements, ensuring timely and precise recording.
• Collaborate with clinical staff to facilitate patient monitoring activities and ensure adherence to study protocols.
• Utilize EMR (Electronic Medical Record) systems and statistical software to organize, analyze, and report clinical data effectively.
• Supervise junior staff or team members involved in data management activities, providing guidance and oversight.
• Maintain thorough documentation review procedures aligned with CDISC standards for data consistency and quality assurance.
• Ensure compliance with all regulatory requirements related to clinical laboratory procedures, blood sampling, phlebotomy, and research protocols.

Requirements

• Proven experience supervising clinical data management teams or projects within a research or healthcare setting.
• Strong knowledge of clinical trials management, including study design, regulatory standards (FDA regulations, ICH GCP), and compliance management.
• Familiarity with medical terminology, clinical laboratory procedures, blood sampling techniques, and vital signs measurement.
• Experience working with EMR systems, statistical software packages, and data collection tools used in clinical research.
• Knowledge of CDISC standards for data formatting and reporting in clinical trials.
• Certification in Good Clinical Practice (GCP) from a recognized issuer or equivalent qualification such as an ICH GCP certificate is highly desirable.
• Background in nursing or phlebotomy is advantageous due to the hands-on nature of patient monitoring tasks.
• Excellent analysis skills with attention to detail for reviewing documentation and ensuring data accuracy.
• Ability to interpret complex regulatory guidelines such as HIPAA compliance requirements relevant to patient information security. Join our team as a Clinical Data Coordinator to play a vital role in advancing medical research through meticulous data management and regulatory excellence!

Pay: From $28.00 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

License/Certification:

• LPN (Preferred)

Work Location: In person

Salary : $28