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 diabetes and its complications. With general supervision, the Clinical Research Coordinator II works with study participants 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.
- 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
- Participate in the training of clinical research staff and may assist in monitoring of their performance.
- Ensure that study visits and relevant 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)
- Minimum 3 years of experience working in clinical research
- Clinical research certification, such as from ACRP or SOCRA, is preferred but not required
- Advanced knowledge of Microsoft Office Suite
- Graphic design/layout skills (to design brochures, flyers, etc.)
- Strong interpersonal, organizational, and communication skills (communicate clearly and effectively via verbal and written instruction)
- Professional and warm in demeanor, especially when relating to study participants and their families
- Attention to detail and ability to concentrate on multiple tasks
- Excellent critical thinking and problem-solving abilities
- Can learn sophisticated concepts and detailed protocols quickly
- Detail oriented, with the ability to prioritize responsibilities – through completion
- Ability to work both independently and collaboratively with other members of the lab, professional staff, and external contacts
- Ability to work with minimal oversight, after training period, and following through on assignments with minimal direction.
- Ability to work constructively as a member of a small team
- Ability to manage administrative complexity arising from multiple concurrent studies.
- Flexible schedule, as necessary, to accommodate study patients and recruitment activities.
- Demonstrated understanding of HIPAA requirements with respect to patient confidentiality