Clinical Research Coordinator I

Overview

The Clinical Research Coordinator’s responsibilities may be associated with one or more clinical research project(s).  The Coordinator works directly with pediatric patients and their families, and is responsible for coordinating assigned study/studies.

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) 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 familiar with relevant 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, measure vital signs and perform 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 study team and investigator
• Maintain up-to-date inventory of study supplies and place orders
• Modify study documents, such as informed consent form and recruitment materials, when needed
• Prepare documents for submission to IRB—may include 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
• Assist with 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 (in a relevant field of study preferred)
• 1-2 years of relevant post-graduate experience preferred
• Fluency in written and spoken English
• Spoken Spanish preferred
• Basic knowledge of Microsoft Office Suite and ability to navigate at a basic level within various web-based applications.
• Graphic design/layout skills (to design brochures, flyers, etc.) desirable
• Ability to follow general instructions and procedures, as provided.
• Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction).
• Meticulous attention to detail
• Professional and warm in demeanor, especially when relating to study participants and their families
• Ability to maintain confidentiality
• Ability to prioritize responsibilities – through completion.
• Ability to work independently and with others in the team - to interact respectfully with other employees, professional staff and/or external contacts.
• Excellent critical thinking and problem-solving abilities
• Ability to learn sophisticated concepts and detailed protocols quickly
• Ability to work with minimal oversight, after training period
• Ability to manage administrative complexity arising from multiple concurrent studies
• Flexible schedule as necessary to accommodate study patients and recruitment activities

The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.

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