Experience as part of a team with all 8 competency domains is expected:
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCP's)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
The major duties and responsibilities will vary somewhat, but may include any of the following:
Recruits patients to studies. Initiates identification, determines eligibility, and conducts recruitment and retention of study subjects per study protocol. Administers to potential study subjects the process of informed consent to participate in research. Complete recruitment activities such as informed consent and assessments with Spanish Speaking participants.
Data collection activities. Assists investigator with the design/modification of data collection instruments and data capture platforms; makes arrangements for and conducts data entry. Works with investigator to: establish and implement procedures for ensuring data quality; review preliminary descriptive statistics from analyses to identify potential problems with data, and initiate corrective action; develop primary data collection/entry protocols, training and procedures manuals; monitor field procedures to determine compliance with protocol. Responsible for primary data collection, primary data entry, or other study activities depending on project needs.
Data collection via semi-structured or structured interviews. May assist with interview guides, schedule interviews with participants at participating sites, participate in detailed qualitative notetaking, conduct semi-structured and structured interviews, assist with development of coding schemes, and data analyses.
Dissemination of results/proposal writing/misc research support. May assist with submission of research proposals. In collaboration with investigators, may prepare sections of working papers, presentations, grant proposals, research reports, regulatory reports, and manuscripts for submission. Conducts literature searches, abstracts articles, prepares summaries and critiques of literature.