As a member of the clinical research team, the Clinical Research Coordinator II 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 and design and implement recruitment methods and mechanisms, as needed
• Assess eligibility of potential study participants
• Become expert on content of all relevant study protocols
• Communicate clinical trial updates to other team members
• Participate actively in training of new study 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 Institutional Review Board (IRB), sponsors, and other entities, as warranted and according to required timelines
• Maintain up-to-date inventory of study supplies and place orders
• Generate and/or modify study documents, such as informed consent form and recruitment materials, when needed
• Prepare documents for submission to IRB, such as 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
• Complete 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 (relevant field of study is preferred)
• 2 years of clinical research experience preferred
• Fluency in written and spoken English
• Meticulous attention to detail
• Excellent critical thinking and problem-solving abilities
• Ability to quickly learn sophisticated concepts and detailed protocols
• Ability to work with minimal oversight, after training period
• Ability to work constructively as a member of a team
• Professional and warm in demeanor, especially when relating to study participants and their families
• Skilled user of Microsoft Office Suite
• Graphic design/layout skills (to design brochures, flyers, etc.) desirable
• Excellent interpersonal, organizational, and communication skills (communicate clearly and effectively via verbal and written instruction).
• Ability to maintain confidentiality
• Skill in working independently and following through on assignments with minimal direction
• Ability to manage administrative complexity arising from multiple concurrent studies
• Flexible schedule as necessary to accommodate study patients and recruitment activities