Records Specialist V

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 60,000 - 75,000; Full time

Job summary

A leading IT staffing firm in the United States seeks a Records Manager to oversee Clinical Documentation activities for study TMFs. The successful candidate will supervise TMF setup, support documentation teams, and ensure quality and completeness of TMF documents. Ideal applicants possess strong knowledge of TMF regulations, at least 1 year of clinical research experience, and excellent communication skills. This role demands the ability to coordinate with various team members and provide metrics on TMF progress.

Qualifications

• At least 1 year experience in clinical research.
• Formal training in GCP methods.
• Understanding of TMF regulations and ICH.

Responsibilities

• Supervise the study TMF set-up in the eTMF/EDMS system.
• Provide support to Clinical Documentation Team.
• Monitor TMF completeness and quality.
• Provide expertise on TMF Management Processes.

Skills

Clinical development process knowledge

GCP methods training

TMF regulations understanding

Knowledge of US Federal Regulations

Records Manager or Clinical Research Associate experience

Fluent English communication skills

Very good interpersonal skills

Job description

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

The Records Manager (RM) is responsible for the oversight of Clinical Documentation activities relating to the management of the study TMFs.

Jon Description:

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 ensure TMF 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 the TMF. He/she provides metrics and TMF progress reports to the Clinical Team.
• Provides support and expertise to the Clinical Trial Team members on the TMF Management Processes and the eTMF/EDMS system. He/she is the contact within the Clinical Team for any TMF related.
• Reports study TMF progress or any issue to the Clinical Team, the Regional Manager, and Records Manager in charge of the program.

Skills:

• Very good knowledge of the clinical development process: at least 1 year experience in clinical research
• Formal training in GCP methods
• 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

Qualifications