- 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
- 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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Clinical Research Coordinator II - Boston, United States - Joslin Diabetes Center
Description
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.
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.
Responsibilities
