Attachment_5_Labor_Category_Descriptions.docx

Attachment 5 Labor Category Descriptions Senior Scientist (KEY PERSONNEL)- Requires a Ph.D. and at least 6 years of experience. Supervises and works alongside other scientists in their daily operations and clinical research. Provides extensive experience and judgment to plan and accomplish goals.

Project Director / Manager(KEY PERSONNEL)- Requires a bachelor's degree and at least 10 years of experience in managing clinical 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.

Data Management Associate(KEY PERSONNEL)- Requires a master's degree and 2-4 years of experience with clinical studies. Manages all aspects of clinical data. Establishes and maintains policies and procedures for gathering, coding, analyzing, and reporting clinical data.

Research Assistant II - Requires a bachelor’s degree and 2-5 years of experience. 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 2-3 years of 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).

Physician – Requires a medical degree and at least 1 year of clinical research experience. Monitors medical procedures and evaluates clinical study safety and participant medical problems within study.

Recruiter 1&2(contract stipulates 2 recruiters)– Requires a bachelor’s degree and 1-2 years of experience in recruiting 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 2-4 years of experience with 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 2-3 years of experience in tobacco-related research. Provides knowledge and experience to recruiters and scientific personnelas needed.Assists with study protocols and final study reports.

Medical Writer - Requires a bachelor's degree and 2-5 years of relevantexperience. Responsible for researching, writing, and editing clinical/statistical reports and study protocols.

Clinical Data Manager –Requires a master’s degree and 2-4 years of experience with clinical studies. Manages all aspects of clinical data. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data.

Pharmacokineticist–Requires a Ph.D. and 3-5 years of experience.Responsible for the design, analysis, and interpretation of clinical pharmacokinetic, bioavailability, bioequivalence, and pharmacodynamicdata.Assists with the preparation of final reports.