Opportunities
Clinical Data Coordinator
Department: Corporate
Reports to: Manager, Clinical Data Management
Overview:Coordinates the development and implementation of clinical data management
project deliverables according to RadPharm’s Standard Operating Procedures
(SOPs).
Responsibilities:
- Review and reconcile data discrepancies within clinical databases
- Generate and manage data clarification forms for query resolution
- Expertise with protocol, charter language and transfer plan creation and review
- Serve as data management representative for a set of assigned studies; liaise with CDM
customers’ representatives; attend internal and external sponsor meetings
- Participate in efficiency and quality improvement initiatives
- Create and update data management documentation as appropriate
- Manage the data collection, review, and cleaning process for assigned studies
- Create and review Data Entry Instructions and Data Review Guidelines under minimal
supervision of senior staff
- Coordinate the creation and revision of forms and source documents under minimal
supervision of senior staff
- In conjunction with the Oracle Clinical team, participate in the creation, design and validation
of clinical databases, including but not limited to the testing of the data entry application,
creation and testing of standard and study specific validation procedures under minimal
supervision of senior staff
- Perform data entry as needed
- Perform quality control review of data
- Review clinical data pre and post-extraction for accuracy and completeness prior to transfer
with minimal supervision of senior staff
- Coordinate multiple studies simultaneously with minimal supervision of senior staff
- Provide training to new employees under supervision of senior staff
- Perform data transfers for all applicable modes of transfer with minimal supervision of senior
staff
- Actively participate in cross-functional Study Teams
- Represent the department and company professionally outwards
Qualifications:
- Undergraduate degree in life science, allied health, or related field preferred and/or
minimum 2 years relevant Clinical Data Management industry experience required
- Proficient with Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat Professional
- Prior CDC/CDM experience with industry standard clinical data management systems (Oracle
Clinical, Clintrial, EDC/RDC) preferred
- Experience with Diagnostic Imaging and Oncology Trials a plus.
- Working knowledge of GCPs
- Excellent written and oral communication skills
- Must be able to prioritize independently depending on project timelines and urgency
- Initiative for improvements is expected
- Responsible and detail oriented with a co-operative and flexible attitude
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