Clinical Data Coordinator

Job Description

Description:

Department: Clinical Data

Position Summary:

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 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.

Position 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 assignedRequirements:

Experience and Skills:

• 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

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 accommodations 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

Education and Experience:

• High school diploma or GED is required; college level is preferred

• Experience in a clinical research setting or related work environment is preferred

• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)

• Familiarity with or ability to learn clinical trial management system software

The above is not an exhaustive list of duties and you will be expected to perform different tasks as

necessitated by your changing role within the organization and the overall business objectives of the

organization

Full-time