Project Manager I Social Sciences Ritchwood
Project Manager I Social Sciences Ritchwood
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1 Vacancy
Job Description
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 COVID19 mitigation.
- Occasional research activity travel between WinstonSalem 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 daytoday 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 participantlevel 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 noncomplex 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 noncomplex 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 noncomplex studies. These are typically repositories survey studies simple observational studies and nonpatient 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 noncomplex 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 protocols 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 noncomplex 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 protocolspecific 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
Bachelors 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. Masters 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
Required Experience:
IC
Employment Type
Full-Time
