Project Manager I, Social Sciences (Ritchwood)

JOB SUMMARY

• The Department of Social Sciences and Health Policy invites applications for a Project Manager I position. Current projects focus on HIV prevention and intervention, and COVID-19 mitigation.
• Occasional research activity travel between Winston-Salem, Charlotte and other areas such as Raleigh/Durham are expected.
• The Project Manager I will be involved in a wide range of study activities, performing a variety of research, data, and other routine/technical research tasks to support the conduct of clinical research.   
• Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data and may train clinical study coordinators, volunteers, or student workers in these tasks.

ESSENTIAL FUNCTIONS

Operations

1. Recognizes when typical agreements are necessary and alerts appropriate parties. 
2. Knowledgeable in regulatory and institutional policies and processes; drafts, develops, and submits IRB protocols and amendments.  May train others in these policies and processes. 
3. Assists with study level documentation and approvals for international studies. 
4. Under supervision, assists with managing study materials including arrival, storage, and handling (requisitions, inventory, and reordering). 
5. Prepares for and provides support for study monitoring.
6. Maintains participant-level documentation outside of the EHR. Follows SOPs and strategies to manage and retain research subjects.
7. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. 
8. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc.
9. Conducts and documents non-complex visits and scripted testing or interviews. 
10. May manage participant payment. 
11. Participates in study team meetings.

Ethics

1. Under supervision may collect information about adverse events, identified in the protocol or investigator brochure. 
2. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. 
3. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. 

Data

1. Enters and collects basic data for research studies. 
2. May score scripted or validated tests and measures. 
3. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. 
4. Follows SOPs for quality assurance. Runs summaries and reports on existing data. 
5. Follows required processes, policies, and systems to ensure data security and provenance. 
6. In addition, recognizes and reports security of physical and electronic data vulnerabilities. 
7. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). 
8. Learns and uses new technology when required.

Science

1. Assists with literature searches. 
2. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). 

Study and Site Management

1. As directed, attends or schedules site visits. 
2. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. 
3. Records basic protocol information in clinical research management system. 
4. Ensures that there are ample supplies and that equipment is in good working order. 
5. Ensures that studies are conducted in compliance with institutional requirements and other policies. 
6. Follows protocol-specific systems and process flows. 
7. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership

1. Maintains institutional and project specific training requirements (e.g. CITI certification). 
2. Keeps current with research updates by attending key external offerings and applies learned material to the position. 
3. Serves on committees and working groups
4. Performs other related duties incidental to the work described herein.

EDUCATION/EXPERIENCE

Bachelor's degree in a relevant discipline such as Psychology, Nursing, or Ba