Revised_Attachment_3_-_Labor_Category_Descriptions.pdf

ID/IQ Labor Categories Descriptions

The staff for each task order will include positions selected from the following labor categories.

Not all categories may be used for each task order. By mutual agreement by the Contractor and the Government, additional labor categories may be added at a later date to the schedule.

Analyst Coder I: Ensures the accuracy of data entered into critical fields according to the Standard Operating Procedures (SOPs); performs data entry functions as needed; and provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors. Experience in using advanced software systems to resolve and handle medical coding of adverse event forms using coding terms.

Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures in each center. Resolve problems related to data entry. Bachelor’s or higher degree must be in related health science, such as physicians, nurses, pharmacists, veterinarians, and/or certified/licensed technicians, as appropriate for each center.

Analyst Coder II: The Analyst Coder II must meet all the qualifications of the Analyst Coder I, as well as being able to perform the following duties: ensures the accuracy of data entered into critical fields, per coding principles and procedures and the Standard Operating Procedures;

performs coding in accordance with the FDA instructions for coding and ICH Coding Principles for documents, and include quality control and quality assurance procedures to ensure appropriate selection of codes; performs data entry functions as needed; provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors; and attends team meetings and training sessions.

Experience and proficiency in the use of advanced software systems to resolve and handle medical coding of adverse event forms using coding terms. Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures in each center. Possess at least 2 years of managerial experience. Interface with internal users as well as external stakeholders. Apply and use project management tools such as MS Projects, spreadsheets, etc. Use and direct personnel to code from Adverse Event Report forms or images of these forms into a relational database using International Medical Terminology; verify medical code and data entry. Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies.

Manage functional task activities and lower level personnel. Bachelor’s degree (Master’s degree preferred). Degrees must be in related health science fields such as Nursing, Pharmacy, Veterinary, and/or Doctorate in Medicine, as appropriate for each center.

Document Imaging Tech: High school graduate or equivalent required. Must have one year health information management or clerical experience with at least six months in a healthcare setting. Basic computer skills and experience required. Ability to examine the record and verify patient identification using multiple systems and applications. Ability to identify non-standard forms and determine action required. Must have good organizational skills and be detail-oriented. Ability to prioritize workload. Must demonstrate ability to perform multiple tasks simultaneously and maintain high productivity and accuracy. Requires good written and communication skills. Must maintain confidentiality with regard to patient information.

Driver Courier: The Courier must possess a minimum of a high school diploma and a valid driver’s license from the state of legal residence and at least 2 years good driving record. In addition, the Courier must be able to lift 40 lbs. Drives automobile or light truck to deliver messages, documents, packages and mail to various business concerns or governmental agencies.

May transport office personnel and visitors, and perform miscellaneous errands, such as carrying mail to and from the post office and sorting or opening incoming and outgoing mail. May obtain receipts for articles delivered and keep a log of items received and delivered. May deliver items to offices and departments within an establishment.

Electronic Document Technician: A high school diploma is required for the Electronic Document Technician position, but a Bachelor’s degree with coursework in Health Science or Information Science is preferred. The Electronic Document Technician will have 5 years of related experience and 2 years of direct experience with the management and processing of both electronic and paper files. This individual will have excellent communication, computer, and customer service skills. They will also be familiar with FDA terminology.

Senior Electronic Document Technician: The Senior Electronic Document Technician will be responsible for the management and oversight of the Electronic Document Room (EDR) operation. The individual will have a Bachelor’s degree in Computer Science or Information Management and 4 years of experience in the Computer Science or Information Management field. The Senior Electronic Document Technician will have excellent leadership, supervisory, training, communication, and records management skills. In addition, the Senior Electronic Document Technician will be detail-oriented and have the skills to maintain databases, electronic files, documentation, and computer tapes.

Program (Contract) Manager: The Program Manager will have at minimum, a Bachelor's or Master’s degree in a technical, business, information/records management discipline. The individual will have a minimum of 10 years of project management experience, preferably in a Federal environment. This will include directing, managing, and coordinating resources and staff across multiple task orders/projects and locations. The Program Manager will have demonstrated knowledge of contracts analysis, contract compliance, document processing, database management, and records management. The Program Manager will have the ability to effectively communicate with the FDA CORs and ensure timely response for all communications and deliverables across all task orders. Professional certification is preferred.

Program System Analyst: The Program System Analyst will provide services when needed on the current database whether requested by FDA or the QAS staff. The Program Systems Analyst must ensure the QASs are able to track the progress of the certificates so that there are no lapses in information during the period of performance. The Program Systems Analyst shall have the requisite experience and familiarity to perform database requests when requested. The System Analyst must have knowledge to maintain database if malfunction or crashes in order to support the QASs during their period of performance.

Project Manager: The Project Manager will have a Bachelor’s degree in a business administration, public administration, or a field closely related to records management. The individual will have demonstrated abilities in the management of similar records projects for a minimum of 8 years, preferably in a contract environment. This individual’s past experience must contain a significant amount of client customer service. The Project Manager will have demonstrated the ability to manage a regulatory document and records management effort including a staff of specialty and line managers. The project manager will possess knowledge of contemporary project management tools and will have a command of the core principles of effective management, including effective delegation, ownership, responsibility development and tracking. The project manager will have demonstrated ability to plan, integrate, and manage life cycle regulatory document operations involving document processing in high volume automated and manual operations and scientific data abstraction operations. The project manager will have the ability to effectively communicate with the COR, FDA management, user organizations, and technical staff. The individual must have an extensive knowledge of life-cycle Records Management processes including experience developing and implementing file plans, records inventories and records disposition schedules.

Quality Assurance Analyst (QAA): The Quality Assurance Analyst will have a four-year college degree, preferably in health or science related field. Responsible for verifying that each functional component of the project follows a defined process, which is in conformance with contractual requirements. Reports findings to project staff, line management of the organization, and the customer, as appropriate. Provides an independent assessment of how the project's development process is being implemented relative to the defined process and recommends methods to optimize the organization's process.

Quality Assurance Specialist (QAS): The Quality Assurance Specialist will have a four-year college degree, preferably in health or science related field. They shall possess excellent computer skills and experience with the querying and use of databases. The QASs shall also function as the vocabulary specialist, having knowledge of and experience with medical devices and device terminology in a commercial environment or in a health information processing environment. The QAS will perform Quality and Control of the data entry and correctness, document control & processing, and the overall quality of the performance of the scope of work.

They shall respond to Export Certificates inquires received from Stakeholders, read & respond to email messages concerning the processing and certification of certificates. The QAS’s shall also respond to policy questions.

Records Management Specialist I: The Records Management Specialist I must possess a minimum of a high school diploma and at least one (1) year of office, records, or computer experience. This individual must be able to work in both a paper and electronic production environment. They must also be able to lift 35 lbs., bend and stretch to reach files, and push a fully loaded mail cart. Records Management Technicians will perform duties such as data entry, barcoding, filing, scanning, mail handling, customer service, and document processing.

Shredding Specialist: The Shredding Specialist must be a high school graduate or equivalent.

Subject Matter Expert: The Subject Matter Expert must possess a minimum of a baccalaureate degree and at least 3 years’ experience in a bioscience or records management related field.

Depending on project position, the person (1) must have the ability to abstract data from biologic applications into an Oracle or Access database and verify data and data entry or (2) must have the ability to develop and implant new file plans for records management.

Supervisor: The Supervisor must possess a minimum of a Bachelor’s degree and at least 4 years of progressively more responsible managerial experience in an information and records management environment. The individual assigned to this position will possess knowledge of contemporary project management tools and will have a command of the core principles of effective management. The individual assigned to this position will develop and maintain SOPs and plan and schedule production and resources to ensure turnaround requirements in these areas are met. This individual will have the ability to effectively communicate with FDA user organizations and technical staff and be able to serve as the project alternate to the Project Manager. The individual should have a general knowledge of life-cycle records management including the use of file plans, records inventories, and records retention schedules. In addition, they should be able to manage the employees and workloads for document room activities including, but not limited to, scanning, document processing, data entry, and paper and electronic file management.

Technical Information Specialist: The Technical Information Specialist must have a high school diploma. A Bachelor’s degree with science or information management coursework is desirable. At least 3 years of experience in an office environment with a records management background is preferred. The individual should have experience with reading and classifying scientific regulatory documents. In addition, they should have excellent oral and written communication skills, excellent customer service skills, working knowledge with the standard Microsoft suite of products, and experience in working areas such as document tracking databases, scanning, and micrographics. Excellent data entry skills and attention to detail is mandatory.

Senior Technical Information Specialist/Senior Task Leader: The Senior Technical Information Specialist will have a college degree in science or information management. This individual will be proficient in reading, analyzing, classifying, and interpreting regulatory submissions. The ability to lead special project teams is preferred, with a minimum of 3 years of experience specifically in records management. This individual will also be able to implement SOPs and train staff in their use. They should have experience with scientific regulatory documents, and excellent speaking, writing, and excellent customer service skills. In addition, the Senior Technical Information Specialist must have an in-depth background with computer use, including a working knowledge of the standard Microsoft suite of products. They should also have experience in areas such as quality control, overseeing document tracking databases, inventorying records, scanning, and micrographics.