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Project Manager I, Social Sciences and Health Policy

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Winston Salem, NC, United States
Job ID: 95690
Job Family: Professional Services
Status: Full Time
Shift: Day
Job Type: Regular
Department Name: 55811085045117-Public Health Sciences-Social Sciences

Overview

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.  Participates 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.

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 

SCOPE OF RESPONSIBILITIES

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.

WORK ENVIRONMENT

Clean, well lit office environment