Clinical Research Coordinator I (Clinical Research Center) (Finance)
Overview
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 diabetes and its complications. The Coordinator works with study participants and 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 expert on content of all relevant study protocols
- Communicate clinical trial updates to other team members.
- Describe studies to potential participants, explaining rationale for and details of participation
- Obtain informed consent
- 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 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 that abnormal findings are reported to investigator in a timely manner
- Document and communicate all serious adverse events and other safety reports to the 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 Institutional Review Board, 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)
- Complete other duties, as assigned
Qualifications
- Bachelor's degree (relevant field of study is preferred)
- Minimum 1 year of experience working in clinical research
- Clinical research certification, such as from ACRP or SOCRA, is preferred but not required
- Fluency in written and spoken English
- Meticulous attention to detail
- Excellent critical thinking and problem-solving abilities
- Can learn sophisticated concepts and detailed protocols quickly
- Ability to work with minimal oversight, after training period
- Ability to work constructively as a member of a small 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.)
- Excellent interpersonal, organizational skills, and communication skills.
- 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.
