Records Specialist

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing company is seeking a Records Manager responsible for overseeing clinical documentation related to study TMFs. The role involves supervising study TMF setup, ensuring quality control of documents, and supporting the clinical team with TMF management processes. Ideal candidates should have at least one year of clinical research experience and a Bachelor's Degree. Strong interpersonal skills and fluent English communication are required. This position offers the chance to contribute to meaningful clinical projects.

Qualifications

• At least 1 year of experience in clinical research is required.
• Very good knowledge of TMF regulations, ICH guidelines, and regulatory agency documents.
• Ideally, previous experience as a Records Manager or Clinical Research Associate is preferred.

Responsibilities

• Oversee clinical documentation management activities.
• Supervise study TMF set-up and develop trial-specific documentation.
• Support documentation teams and ensure TMF document quality.
• Monitor TMF completeness and provide progress reports.
• Act as a point of contact for TMF management processes.

Skills

Knowledge of the clinical development process

Knowledge of TMF regulations

Knowledge of the Code of Federal Regulations

Fluent English communication skills

Very good interpersonal skills

Education

Bachelor's Degree or equivalent qualification/experience

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.
• 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

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