Records Specialist Job at Artech Information System LLC in Swiftwater

Posted 3 days ago

artech information systemSwiftwater (PA)

Document Management Specialists Document Preparation Services

SENIORITY

Lead

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About the role

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description:

T he Records Manager (RM) is responsible for the oversight of Clinical Documentation activities relating to the management of the study TMFs.
The RM is a member of the Clinical Team and is responsible for the following activities for their trials:
Supervises the study TMF set-up in the eTMF/EDMS system and develops any trial-specific instructions/documentation for the Clinical Documentation Team.

Provides support and direction to the Clinical Documentation Coordinators, Clinical Documentation Administrators and Clinical Documentation partner CROs in the processing of the TMF documents in order to ensureTMF Document Quality(document legibility, minimum content check), proper indexing /filing (both paper and electronic) and real-time management of documents submitted to the TMF. Acts as a back-up for Clinical Documentation Coordinators. Monitors the completeness and quality of theTMF.He/she provides metrics andTMFprogress reports to the Clinical Team. Provides support and expertise to the Clinical Trial Team members on theTMF Management Processes and theeTMF/EDMSsystem. He/she is the contact within the Clinical Team for anyTMFrelated. Reports study TMF progress or any issue to the Clinical Team, the Regional Manager, and Records Manager in charge of the program

Qualifications

Skills:

Very good knowledge of the clinical development process: at least 1 year experience in clinical research
Very Good knowledge of the TMF regulations, ICH, etc.
Knowledge of Code of Federal Regulations (US) and regulatory agency documents
Ideally previous experience as a Records Manager or Clinical Research Associate.
Fluent English communication skills, verbal and written
Very good interpersonal skills - ability to work with individuals at different levels

Education: Bachelors’ Degree or equivalent qualification/experience

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