Senior Clinical Data Coordinator at Johnson County Clintrials LLC

Lenexa, Kansas, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

60000.0

Posted On

27 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Source Data Review, Query Management, SAE Review, Data Reconciliation, Data Quality, Clinical Trial Data, Regulatory Compliance, Data Cleaning, Protocol Adherence, Interpersonal Communication, Analytical Skills, Problem-Solving, Medical Terminology, Project Management, Database Lock, Data Listing Review

Industry

Research Services

Description

Description Position: Senior Clinical Data Coordinator Location: JCCT Lenexa, KS Department: Clinical Data Purpose: 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. Position Summary: 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. Key Responsibilities (Essential Functions): 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 Education and Experience: Required 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 Preferred Bachelor’s degree in related discipline Certified Clinical Research Professional Leadership experience Skills and Competencies: Subject matter expert with study protocols, ICF and sponsor provided documents 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 Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 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 Why JCCT? JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States. We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment. Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today! EEO JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Responsibilities

This role ensures the accuracy and integrity of clinical trial data by performing source data review, query management, and SAE review across multiple research sites to support data management plans. The coordinator will also assist the Principal Clinical Data Manager in planning operational activities, supporting team members, and developing process documentation.