Clinical Data Coordinator
About The Position
The Clinical Data Coordinator position is responsible for coordinating the delivery of clinical research data to sponsors. The position will work with clinical research team members to ensure that accurate information is collected and entered appropriately. The Clinical Data Coordinator completes CRFs, manages routine queries, and reconciles source documentation against protocol data standards. The Clinical Data Coordinator will support data quality and the data management plan by performing reconciliation of source documentation and data entry within multiple clinical databases and information systems. This position reports to the Senior Clinical Data Coordinator.
Requirements
- Familiarity with study protocols, ICF and sponsor provided documents
- Microsoft Office Suite proficiency
- Excellent written, verbal and interpersonal communication skills
- Knowledge of medical terminology and concepts
- Proficient typing and data entry skills
- Ability to work effectively with a team
- Ability to manage small projects personally and work independently
- Memory to retain information and know where to research answers
- Time management skills
- Organizational skills
- Detail oriented with the ability to perform at a high level of accuracy
- Demonstrates strong analytical and problem-solving skills
- Self-motivated
- Must be results oriented, able to multi-task, and a quick learner
- Respond to the urgent needs of the team and show a strong track record of meeting deadlines
- BS/BA preferred OR equivalent experience
- Typically, 1–3 years data or clinical research experience
- Independent query resolution demonstrated
Responsibilities
- Reviews and processes clinical trial data to ensure completeness, accuracy and consistency
- Utilizes study protocol, ICF and sponsor provided documents as a resource
- Performs data cleaning activities including reviewing errors from electronic checks and manually reviewing data listings to verify quality and the completeness of data
- Works closely with clinical research team members to prepare and ensure proper execution of data management plans and manage data management projects from the beginning to the end
- Participates in the review of CRF/eCRF database
- Transcribes information from the source documents to CRFs
- Visually reviews individual case report forms and datasets to find patterns
- Investigates and resolves data discrepancies
- Answers and tracks queries based on data review and publication goals
- Develops and runs data reports
- Identifies potential study issues/risks and recommends solutions
- Supports the Data Entry Manager in executing the data management plan
- Designs and modifies source documents, extracts, and monitors the trial data to identify issues
- Works with clinical research team members to review data and highlight inconsistencies
- Assists clinical teams to facilitate the clinical team review of system and/or specifications
- Assists with data management for startup activities, database cleaning and lock activities, including the review and development of source documents and data management plans
- Other duties as assigned
- Complete case report forms accurately and timely
- Resolve routine data queries independently; escalate complex queries
- Reconcile source documents against CRF entries
- Maintain data documentation per ALCOA+ and study data standards
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
