Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.

Key Tasks

1. Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

2. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

3. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

4. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

5. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.

6. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

7. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.

8 Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

9. Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

10. Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, or potential subject risks.

11. Code, evaluate, or interpret collected study data.

12. Participate in the preparation and management of research budgets and monetary disbursements.

Technology Skills

Accounting software — Budgeting software

Analytical or scientific software — InferMed MACRO Electronic Data Capture; SAS ; StataCorp Stata; The MathWorks MATLAB 

Calendar and scheduling software — Scheduling software

Categorization or classification software — Drug coding software

Data base user interface and query software — FileMaker Pro; Microsoft Access  ; Oracle Clinical; PPD Patient Profiles 

Electronic mail software — Microsoft Outlook

Internet browser software — Web browser software

Medical software — Patient tracking software

Key Knowledge Areas

English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

Medicine and Dentistry — Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.

Administration and Management — Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

Mathematics — Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

Skills 

Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Coordination — Adjusting actions in relation to others' actions.

Reading Comprehension — Understanding written sentences and paragraphs in work related documents.

Writing — Communicating effectively in writing as appropriate for the needs of the audience.

Speaking — Talking to others to convey information effectively.

Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Management of Personnel Resources — Motivating, developing, and directing people as they work, identifying the best people for the job.

Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Time Management — Managing one's own time and the time of others.