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Document Management Specialist - Clinical
- Job Title
- Document Management Specialist - Clinical
- Job ID
- Bethesda, MD 20892
- Other Location
The Document Management Specialist proactively assists both the Clinical Project Manager and Deputy Clinical Project Manager in the abstraction/extraction of clinical data and maintaining quality control of all documents and key data elements. The Document Management Specialist will assist in the successful implementation and monitoring of clinical trial data and documents to ensure that data collection from DCP Databases and related applications are accurate, clean, and complete.
Under the supervision of the Division of Cancer Prevention (DCP), Clinical Project Manager, and Deputy Clinical Project Manager the responsibilities relative to the management of Clinical Trial data will include, but will not be limited to:
- Provide support abstraction of clinical data from both (hardcopy and softcopy) into client database.
- Abstraction of data element keywords and milestones into the DCP Clinical Trial Systems and Cancer Therapy Evaluation Program (CTEP) Enterprise/Abstraction System.
- Serve as central communication hub for all document-related correspondence.
- Facilitator of entire protocol development process
- Provide inventory supported of hardcopy and softcopy files.
- Maintain a filing system and track documents and files related to clinical trial.
- Participate in meetings with DCP staff as needed.
- Develop document processes and tools as needed.
- Perform quality control of data relating to people, organizations, and relationships of people in client database.
- Facilitate and track reviews for Central Institutional Review Board (CIRB) DCP clinical trials.
- Compile reviewer comments, review/modify existing correspondence, and develop templates as needed
- Provide routine and AD HOC reports to client staff.
- Provide education to DCP staff and collaborators on administrative policies and procedures regarding clinical trial development and management.
- Knowledge and experience with the Oncology Community.
- Experience with (but not limited to) Clinical Trial databases.
- Experience in clinical trial protocol processes.
- Knowledge of clinical medical terminology.
- Strong written and verbal communication skills.
- Strong interpersonal skills.
- Accurately extract data from various sources.
- Excellent time management skills.
- Ability to interact with all levels of managements.
- Ability to efficiently multi-task and support various phases of data extraction and perform quality assurance as to the accuracy of extracted data.
- Experience with data entry into various databases and/or alternate forms of media.
- Ability to prioritize and execute tasks in a high-pressure environment.
- Proficient computer skills in Microsoft Office Suite.
- Bachelor's Degree in informatics, statistics, biostatistics, project management, data management or related field.
- Minimum 1-2 years Clinical Trial Data documentation experience.