Senior Data Coordinator
Premier Research - Quincy, MA

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POSITION SUMMARY:
Primary responsibility is to serve as a member of the project team with the lead responsibility for reviewing CRFs, data listings, and databases to ensure that all captured data follow the rules outlined by the protocol and data management plan. Also responsible for the preparation of data management plans, data entry guidlines, data management reports, and other documents required for preparing and completing databases. When a Biometrics Project Manager is allocated on a study, acts as the Data Operations point of contact for all data management responsibilities when designated as the Data Management Team Leader (Core Team Representative).

PRIMARY JOB FUNCTIONS:
Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan

Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process

Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly

Reconciles third party data with CDMS data

Tracks CRFs as they are processed through the data management department

Interacts with the Biometrics Project Manager on a continual basis throughout the course of the study, when applicable

Coordinates and acts as point of contact for all data operations responsibilities related to data management when designated as the Data Management Lead for the Premier Research project team

Prepares data management plans, data entry guidlines, data management reports, and other documents required for preparing and completing databases, when requested

Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, financial status and provides feedback to the project team, when requested

Mentors newly hired associate data coordinators or data coordinators

All other projects as assigned

OTHER RESPONSIBILITIES:
Quality control reviews output of the clinical database (entry screens or data listings) against primary documents (e.g. data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions

Assists in writing quality control reports in a timely and concise manner according to PRG standard operating procedures

Ability to perform overnight business travel, up to 10%

Required Skills

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Educated to Bachelor's degree level, or equivalent. In lieu of this qualification, three (3) years experience in clinical research, drug development or a healthcare environment will be required

In addition to this a minimum of three (3) years of clinical data management experience. Alternatively, must have proven experience in all primary job functions

Understanding and experience with up-to-date MS Windows Operating Systems and applications and at least one Database Management System (e.g. SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc.)

Attention to detail and ability to independently resolve a variety of issues without close supervision

Organizational and planning skills

Working knowledge of medical terminology

Fluent English communication skills (verbal, written, and interpersonal)

Excellent customer service

Enjoys working collaboratively as part of a team

Capable of multi-task orientation

Required Experience

Premier Research - 17 months ago - save job - block
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