Senior Clinical Data Coordinator

Johnson County Clintrials LLC•Lenexa, KS

5d•Onsite

About The Position

The Senior Clinical Data Coordinator plays a critical role in ensuring the accuracy, integrity, and readiness of clinical trial data across multiple national research sites. This position supports the execution of data management plans by performing in-depth source data review, reconciliation, query management, and serious adverse event (SAE) review to ensure high-quality, consistent, and regulatory-compliant clinical data. The Senior Clinical Data Coordinator will work with clinical research team members across multiple national sites to ensure that accurate information is collected and entered appropriately. The Senior 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 is a role for an individual with previous industry-specific experience in clinical data at the site level. The Senior Clinical Data Coordinator is expected to fulfill all responsibilities, including performing SAE (serious adverse event) and source review as required. While this is not a supervisory position, the Senior Clinical Data Coordinator is expected to serve as a resource to other Clinical Data Coordinators. This position reports to the Principal Clinical Data Manager. Please note this is not a Data Management role. JCCT is a clinical trial site and does not create or program eCRF systems.

Requirements

Minimum two years’ experience as a Clinical Data Coordinator or similar role
Expertise of regulations governing clinical research (CFR, GCP, HIPAA)
Expertise with clinical trial management system software
Excellent written, verbal and interpersonal communication skills
Knowledge of medical terminology and concepts
Ability to work effectively with a team
Ability to manage projects personally and work independently
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
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds

Nice To Haves

Bachelor’s degree in related discipline
Certified Clinical Research Professional
Leadership experience

Responsibilities

Assists the Principal Clinical Data Manager plan, direct, and coordinate the operational activities of the Clinical Data Coordinator team
Assists Clinical Data Coordinator team members with any questions regarding specific study related questions
Assists in the development of edit specifications based on any available global medical standards and study protocol information used to clean the study
Creates supporting Data process documentation to the Principal Clinical Data Manager and/or performs peer review of documentation including updating documentation
Performs manual data listing reviews and submits internal queries, as appropriate
Performs the review of lab value results versus normal results
Evaluates the quality of lab data entry and addresses inconsistencies with site staff, as applicable
Assists in the SAE reconciliation process that may include coordination with the Investigator team
Follows up on discrepancies and finds resolutions so databases are consistent
Coordinates and reviews medical and statistical queries and certify that they are adequately resolved
Assists in developing and generating study report listings according to the ICH and company guidelines
Coordinates the query management system functions
Performs the final patient review and database lock activities
Review query responses and ensure data quality
Attend and may lead team meetings while ensuring meeting minutes are taken
Supports training and development of the Clinical Data Coordinator team
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 Primary Clinical Data Coordinator 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
Assists Clinical Data Coordinators with inquiries
Works directly with the Principal Clinical Data Manager to ensure the workflow of the department
Supports the Principal Clinical Data Manager with performance reviews and recognition, if required
Ability to empower fellow team members and delegate authority, as necessary
Manages change effectively as it happens
Participates in improving efficiency, quality, and cooperation
Maintains morale and supports employee engagement initiatives