Research Project Management - 40 Hrs/Wk - Days - Detroit

GENERAL SUMMARY:
Work closely on one or more moderately complex projects/assignments in collaboration with the Principal investigator and/or Epidemiologist(s). Manage significant and key aspects of one or more small to moderate Research Projects from start-up to closeout. Oversee day-to-day operations of team members working on assigned studies and projects. Will work in the department of Public Health Sciences.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
Regulatory compliance:
1. Ensure compliance with research protocols and regulatory standards to ensure procedural and data completion and accuracy.
2. Educate research staff on established policies, processes, and procedures.
3. Prepare and manage regulatory submissions and ensure Institutional Review Board renewals are completed. Contribute to development of consent forms for approval by IRB.
4. Monitor and report adverse events, deviations as well as other privacy and safety incidents.
5. Maintain project documents and regulatory binders
Recruitment and oversight:
1. Assist PI and/or Epi in determining effective strategies for promoting/recruiting research participants and retaining participants in long-term research studies/projects
2. Develop and manage recruitment team schedules
3. Assist PI and/or Epi in setting up recruitment space/clinics in collaboration with clinic staff
4. Oversee specimen collection process by research staff
5. Oversee management and distribution of study related incentives
Project Management:
1. Serve as primary contact for research participants, sponsors, and regulatory agencies.
2. Lead project development and team meetings, prepare/approve agendas, minutes etc. and keep current on industry methods and trends.
3. Manage and oversee study databases or other operational infrastructures.
4. Monitor staffing levels and may represent the research team in the hiring of project team members under the direction of department managers.
5. Assist PI and/or Epi in managing project schedules, targets, measurements, and accountabilities.
6. Track patient and study specific milestones per NOA or contract agreements, developing necessary reports and dashboards.
Support:
1. Assist in developing study budget and relevant contracts with grant manager and principal investigator. Assist Grant Managers in monitoring expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff
2. May assist with analysis of data and preparation of abstracts, manuscripts, and scientific presentations.
EDUCATION/EXPERIENCE REQUIRED:
• Bachelor's degree in a related field and five (5) years of relevant experience; Experience leading cross functional teams or a small to moderate sized project. OR
• Master's degree in a related field.
• Strong customer service, critical thinking and interpersonal skills required.
• Experience working in a team orientated environment and comfortable working with cross-functional teams required.
• Proficiency with Microsoft Office and a general knowledge of medical terminology preferred.
CERTIFICATIONS/LICENSURES REQUIRED:
• CAP-M or PMI Project Management Professional certification or similar preferred.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.