Job Description
Job DescriptionDescription:
Position: Clinical Data Coordinator II
Location: Remote (Kansas)
Department: Data Services
Purpose:
The Clinical Data Coordinator II is responsible for ensuring the accurate, timely, and high-quality coordination of clinical research data across multisite clinical trials. This role supports the integrity of study data by performing advanced data review, reconciliation, and source verification activities in alignment with study protocols, sponsor requirements, and data management plans. Working with a high degree of independence, the Clinical Data Coordinator II serves as a key partner to the clinical research team and Principal Clinical Data Manager, proactively identifying data quality issues, resolving discrepancies, and supporting study execution from startup through database lock to deliver reliable data to sponsors.
Position Summary:
The Clinical Data Coordinator II position is responsible for coordinating the delivery of multisite 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 II 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.
The Clinical Data Coordinator II is expected to fulfill all Clinical Data Coordinator I responsibilities at an advanced level with a high level of autonomy.
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.
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):
- 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 Principal Clinical Data 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
Education and Experience:
- High school diploma or GED is required; college level is preferred
- Minimum one year experience as a Clinical Data Coordinator I, similar role, or manager recommendation
- Understanding of regulations governing clinical research (CFR, GCP, HIPAA)
- Familiarity with clinical trial management system software
Skills and Competencies:
- Skilled 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
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.
Requirements: