What are the responsibilities and job description for the Project Manager I, Social Sciences (Ritchwood) position at Wake Forest Baptist Health?
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
- Recognizes when typical agreements are necessary and alerts appropriate parties.
- Knowledgeable in regulatory and institutional policies and processes; drafts, develops, and submits IRB protocols and amendments. May train others in these policies and processes.
- Assists with study level documentation and approvals for international studies.
- Under supervision, assists with managing study materials including arrival, storage, and handling (requisitions, inventory, and reordering).
- Prepares for and provides support for study monitoring.
- Maintains participant-level documentation outside of the EHR. Follows SOPs and strategies to manage and retain research subjects.
- 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.
- Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc.
- Conducts and documents non-complex visits and scripted testing or interviews.
- May manage participant payment.
- Participates in study team meetings.
Ethics
- Under supervision may collect information about adverse events, identified in the protocol or investigator brochure.
- 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.
- Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
- Enters and collects basic data for research studies.
- May score scripted or validated tests and measures.
- Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.
- Follows SOPs for quality assurance. Runs summaries and reports on existing data.
- Follows required processes, policies, and systems to ensure data security and provenance.
- In addition, recognizes and reports security of physical and electronic data vulnerabilities.
- 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.).
- Learns and uses new technology when required.
Science
- Assists with literature searches.
- Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies).
Study and Site Management
- As directed, attends or schedules site visits.
- Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
- Records basic protocol information in clinical research management system.
- Ensures that there are ample supplies and that equipment is in good working order.
- Ensures that studies are conducted in compliance with institutional requirements and other policies.
- Follows protocol-specific systems and process flows.
- As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Leadership
- Maintains institutional and project specific training requirements (e.g. CITI certification).
- Keeps current with research updates by attending key external offerings and applies learned material to the position.
- Serves on committees and working groups
- Performs other related duties incidental to the work described herein.
EDUCATION/EXPERIENCE
Bachelor's degree in a relevant discipline such as Psychology, Nursing, or Basic Science with three years of relevant administrative and medical experience in research projects or other health related activities; or, an equivalent combination of education and experience. Supervisory ability. Master's degree in a relevant discipline with experience beyond three years preferred.
SKILLS/QUALIFICATIONS
- Excellent oral, written, and interpersonal communication skills
- Demonstrates knowledge of scientific principles
WORK ENVIRONMENT
Clean, well lit office environment
