MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
Working under general supervision, is responsible for ensuring the integrity of the clinical data both in the clinical
database. This position is responsible for entering, reviewing, verifying, modifying and
organizing incoming clinical data. Identifies potential issues that could affect the quality of clinical data and
forwards to appropriate personnel. Provides administrative support for the clinical study as needed and
identifies solutions to continue to improve efficiency and quality in the data management process. Responsible
for clarifying missing data with external customers. Exercises basic judgment in planning, organizing and
performing work. Assures that quality of services meets internal and external customer requirements. This
position will have primary responsibility for assigned studies with a basic knowledge of all studies managed by
clinical data group.
MAIN RESPONSIBILITIES
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Primary Responsibility will be working with Clinical Data, particularly reconciling the images required by the study that are captured at the site level on Case Report forms with images uploaded by the clinical site to a third-party image repository. This also includes issuing queries to the clinical site for missing images. Reviewing query responses from the site and verification that the image was uploaded in the 3rd party image platform. In addition, also involves reconciliation of the CRF data, Third Party Image platform with the corelab that will perform the actual analysis. Other responsibilities included reconciliation of key identification fields of the CRF, 3rd party image platform, and corelab.
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Responsible for processing incoming clinical data forms accurately and according to departmental processes. This will include the accurate and timely entry of clinical data forms into a database, the quality review and verification of forms already entered, the identification and correction of errors, and the organization of clinical documentation (clinical data forms, correspondence and other supporting clinical documentation).
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Supports discrepancy management effort by preparing data clarification forms based on review of incoming clinical data for missing/incorrect information.
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Responsible for identifying problems and discussing the issues in the area of clinical data coordination.
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Responsible for maintaining the integrity of information stored in the clinical database through critical review of clinical data forms and the identification of discrepancies. Also responsible for ensuring the integrity of meta data study information, which includes the maintenance of hospital, physicians, and other study
Responsible for providing support to the clinical evaluation department in preparation for on-site monitoring visits.
Resolves and/or facilitates resolution of problems including identifying causes of problems to prevent reocurrence of problems.
Remains current on developments in field(s) of expertise.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS
EDUCATION
Education Level
Major/Field of Study
Or
Education Level
High School Diploma / GED
Or other specialized training/equivalent related experience.
☒
an equivalent combination of education and work experience
EXPERIENCE/BACKGROUND
Experience
Experience Details
Minimum 2 years
Demonstrated experience as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
Requires knowledge of the practices and procedures of the function, company products, policies and
programs.
Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision,
and the ability to handle multiple projects simultaneously.
Demonstrated interpersonal skills, including the ability to listen, resolve relatively complex problems,
deal with unresolved issues, delays and unexpected events, while effectively communicating and
maintaining rapport with field clinical engineers and study coordinators.
Must be able to use discretion and handle sensitive/confidential information.
Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP)
regulations as they apply to Clinical Data Management and to the clinical trial process.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the
organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Minimal travel required.
Ability to maintain regular and predictable attendance.
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