As a member of the clinical research team, the Clinical Research Coordinator I contributes to the conduct of a portfolio of clinical research protocols related to the prevention and treatment of type 1 diabetes. The Coordinator works with study participants and their families and performs a variety of study operations duties.

As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.

• In all activities, adhere to Good Clinical Practice guidelines and maintain patient confidentiality per HIPAA regulations
• Identify potentially eligible participants using appropriate data sources
• Assess eligibility of potential study participants
• Become familiar with relevant content of all relevant study protocols
• Communicate clinical trial updates to other team members
• Describe studies to potential participants, explain rationale for and details of participation
• Obtain informed consent and assent, when appropriate
• Schedule study visits and prepare relevant materials for each visit (tubes, paperwork, etc.)
• Arrange participant travel, as applicable
• Collect primary data from study participants and their guardians
• After completing training, perform phlebotomy, measure vital signs, perform EKG and other relevant procedures and tests
• Ensure that study visits and source documents are completed in accordance with study protocols, including verifying the work of other staff members
• Enter data into electronic data capture forms and respond to queries
• Process laboratory samples and ship to central laboratories
• Ensure timely reporting of abnormal findings to investigator and participants
• Document and communicate all serious adverse events and other safety reports to the study team and investigator
• Maintain up-to-date inventory of study supplies and place orders
• Modify study documents, such as informed consent form and recruitment materials, when needed
• Prepare documents for submission to IRBmay include initial protocol submissions, protocol amendments, annual continuing review, etc.
• Maintain all regulatory and subject binders in audit-ready condition
• Correspond with study sponsors, contract research organizations, and other collaborators, as applicable
• Assist with study start-up and close-out activities, as relevant
• Participate in study teleconferences, attend team meetings, and attend national meetings and/or investigator meetings, as relevant (may involve travel)
• Participate in occasional off-site recruitment events (requires some schedule flexibility)
• Other duties as assigned

• Bachelors degree (in a relevant field of study preferred)
• 0-2 years of relevant post-graduate experience preferred
• Fluency in written and spoken English
• Basic knowledge of Microsoft Office Suite and ability to navigate at a basic level within various web-based applications.
• Graphic design/layout skills (to design brochures, flyers, etc.) desirable
• Ability to follow general instructions and procedures, as provided.
• Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction).
• Meticulous attention to detail
• Professional and warm in demeanor, especially when relating to study participants and their families
• Ability to maintain confidentiality
• Ability to prioritize responsibilities through completion.
• Ability to work independently and with others in the team - to interact respectfully with other employees, professional staff and/or external contacts.
• Excellent critical thinking and problem-solving abilities
• Ability to learn sophisticated concepts and detailed protocols quickly
• Ability to work with minimal oversight, after training period
• Ability to manage administrative complexity arising from multiple concurrent studies
• Flexible schedule as necessary to accommodate study patients and recruitment activities