Job Description
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 ofdata management plans and manage data management projects from the beginning to the end
Participates in the review of CRF / eCRF databaseTranscribes information from the source documents to CRFsVisually reviews individual case report forms and datasets to find patternsInvestigates and resolves data discrepanciesAnswers and tracks queries based on data review and publication goalsDevelops and runs data reportsIdentifies potential study issues / risks and recommends solutionsSupports the Data Entry Manager in executing the data management planDesigns and modifies source documents, extracts, and monitors the trial data to identify issuesWorks with clinical research team members to review data and highlight inconsistenciesAssists clinical teams to facilitate the clinical team review of system and / or specificationsAssists 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 documentsMicrosoft Office Suite proficiencyExcellent written, verbal and interpersonal communication skillsKnowledge of medical terminology and conceptsProficient typing and data entry skillsAbility to work effectively with a teamAbility to manage small projects personally and work independentlyMemory to retain information and know where to research answersTime management skillsOrganizational skillsDetail oriented with the ability to perform at a high level of accuracyDemonstrates strong analytical and problem-solving skillsSelf-motivatedMust be results oriented, able to multi-task, and a quick learnerRespond to the urgent needs of the team and show a strong track record of meeting deadlinesPhysical 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 handleor feel
Ability to lift and / or move up to 20 poundsEducation and Experience :
High school diploma or GED is required; college level is preferredExperience in a clinical research setting or related work environment is preferredBasic understanding of regulations governing clinical research (CFR, GCP, HIPAA)Familiarity with or ability to learn clinical trial management system softwareThe 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
