Joslin Diabetes Center
Clinical Research Coordinator II (Immunobiology)
Joslin Diabetes Center, Boston, Massachusetts, us, 02298
OverviewAs 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.
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 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
Qualifications
Bachelor’s 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
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.
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 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
Qualifications
Bachelor’s 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