Attachment_D-Labor_Category_Descriptions.pdf

Labor Category Descriptions

Clinical Data Manager (KEY PERSONNEL) - Requires a master's degree and experience managing data associated with at least 3 clinical research studies. Manages all aspects of clinical data. Establishes and maintains policies and procedures for gathering, coding, analyzing, and reporting clinical data.

Project Director / Manager (KEY PERSONNEL) - Requires a bachelor's degree and extensive experience in managing clinical research studies. Organizes, directs, and manages support services for all activities covered by this contract. Ensures adherence to master plans and schedules, develops solutions to program problems, and directs work of incumbents assigned to program from various departments. Ensures projects are completed on time and within budget.

Senior Scientist (KEY PERSONNEL) - Requires a Ph.D. and experience as lead scientist on at least 3 clinical research projects. Supervises and works alongside other scientists in their daily operations and clinical research. Provides extensive experience and judgment to plan and accomplish goals.

Scientist – Requires a Ph.D. and experience on at least 2 clinical research projects. Conducts daily operations and clinical research. Provides expertise and judgment to plan and accomplish goals.

Data Management Associate - Requires a master's degree and experience managing data associated with at least 2 research studies. Establishes and maintains policies and procedures for gathering, coding, analyzing, and reporting data.

Research Assistant II - Requires a bachelor’s degree and experience in designing and executing clinical studies. Participates in the design, administration, and monitoring of clinical studies.

Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives.

Laboratory Technician II - Requires a bachelor's degree and experience in assaying blood and urine samples. Performs research activities and other tasks as necessary in a laboratory environment. Records observations and measurements and reports results.

Registered Nurse – Requires a bachelor’s degree and Registered Nurse certification. Performs general patient examinations and procedures (such as blood collection, BP, and HR).

Recruiter 1&2 (contract stipulates 2 recruiters) – Requires a bachelor’s degree and experience in subject recruitment for clinical studies. Determines and/or develops optimum recruitment method. Recruits subjects and assesses their inclusion/exclusion criteria.

Statistician - Requires a master's degree and experience with statistics for clinical studies. Uses power analysis to determine proper sampling size for clinical studies. Analyzes data and compiles reports, charts, and tables based on established statistical methods.

Subject Matter Expert – Requires a Ph.D. and extensive experience and knowledge in tobacco-related research. Provides knowledge and experience to recruiters and scientific personnel as needed. Assists with study protocols and final study reports.

Pharmacokineticist – Requires a Ph.D. and experience in evaluating pharmacokinetic data in at least 2 clinical research studies. Provides extensive experience and judgment to plan and analyze clinical data.