Clinical Research Manager

Tufts University School of Medicine- Department of Molecular Biology and Microbiology's mission is to improve global health by using molecular genetics and innovation to address fundamental and medically related problems in microbiology. Training is a core tenet of our approach, and our students, postdocs, and staff are key drivers of our scientific impact. We are committed to fostering a diverse scientific community and aim to improve our core values by promoting inclusivity, diversity, and antiracism. Our department was founded with community building, mentorship, and collaboration as central values, and we continue to prioritize this culture in our department. We believe that fostering an environment that welcomes a diversity of perspectives will lead to more innovative and impactful science.

The Clinical Research Manager is responsible for the management of a highly collaborative research project. They will develop, write and implement established IRB study protocols for clinical research studies in the department. They will manage the required forms and processes for study participation. The Clinical Research Manager will actively conduct subject interviews, lead patient visits, administer questionnaires, perform phlebotomy and collect samples or data. They will be involved with overseeing strategies and processes for recruitment of participants and community outreach including screening, scheduling and enrolling subjects. In addition, they be responsible for data collection and management, including data review and analysis and drafts results. They will oversee data collection and management. They will train and supervise staff and be an integral part of a larger research team working on Lyme Disease. They will work with the Principal Investigator on writing reports and manuscripts for publication as well as applications for grants and contracts, as applicable. The majority of the position can be done from home or from the Tufts University School of Medicine. If working from home, access to a stable internet connection is required. This position will require travel to patient's homes to draw blood, so a Driver's licenses and access to a car are necessary

• Enroll and consent research subjects, administer survey questionnaires, travel to subject locations to draw blood and collect specimens
  
• Designs data collection forms, survey instruments and study databases including data quality control procedures
  
• Develops and updates participant informed consent documents; explains research study, protocol, and consent process to potential subjects.
  
• Oversees regulatory compliance and federal guidelines including good clinical practices, IRB and other sponsor requirements; helps with site initiation visits
  
• Hires, trains and evaluates research staff on protocols
  
• Oversees the data collection and entry process, reviews and validates data including, updating databases, maintains manuals, perform quality control checks
  
• Develops and oversees recruitment strategies and community outreach and cultivates new recruitment sources; schedules follow up visits, arranges payments to subjects, helps prepare billing for contractors
  
• Drafts preliminary findings, reports, presentations and manuscripts for publication with the Principal Investigator
  
• Working with Principal Investigator, develops and writes documentation for research study protocols. Develops all written and electronic recruitment materials and advertisements

Basic Requirements:

• Typically requires skills obtained via an advanced degree (Master's, PharmD, RN or MD)
• 3-5 years' experience managing clinical studies
• Experience with writing clinical IRB protocols and SOPs
• Driver's license with access to car and willingness to travel
• Willingness to perform phlebotomy (training can be provided)

Preferred Qualifications:

• Familiarity with online databases (RedCap)

• Travel is required to clinical sites. Hybrid work environment