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.
Responsibilities
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 IRB-may 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
Qualifications
Bachelor's 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.
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
