Clinical Research Coordinator II

3 weeks ago

Boston Massachusetts, United States Joslin Diabetes Center Full time
Overview:
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.

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

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