Clinical Research Coordinator

Howard Brown Health•Chicago, IL

About The Position

The Clinical Research Coordinator supports clinical research staff and manages new and ongoing clinical research activities. The role assists clinical investigators and research staff in moving projects forward and works closely with external clinical research organizations and sponsors. It includes preparing study documentation such as protocols, amendments, case report forms, Serious Adverse Event reports, and study reports. The coordinator follows GCP, ICH, and FDA guidelines when conducting study-related activities.

Requirements

  • Bachelor of Science or Bachelor of Arts degree and at least 2 years of clinical research experience; alternatively, an Associate of Arts or Associate of Science degree and at least 5 years of clinical research experience; or a high school diploma or equivalent and at least 8 years of clinical research experience.
  • Strong writing skills and the ability to write clearly.
  • Strong organizational and communication skills.
  • Strong attention to detail and the ability to take initiative.
  • Ability to prioritize and multitask in a team setting or independently.
  • Working knowledge of general medical terminology.
  • Working knowledge of industry regulations, standards, and guidance.
  • Ability to communicate effectively with physicians, nurses, pharmaceutical companies, and other team members.

Nice To Haves

  • Bachelor's degree in a healthcare field or life science.
  • Certified Clinical Research Coordinator.

Responsibilities

  • Coordinate assigned trials as directed by the Clinical Research Manager, including data coordination and research-data quality control.
  • Provide backup and support across areas of clinical research.
  • Complete regulatory paperwork for IRB submissions, annual reviews, and study close-out.
  • Report Serious Adverse Events to the IRB and sponsor in a timely manner.
  • Create and update the Regulatory Binder for each assigned study.
  • Assist with monitoring visits.
  • Liaise with study sponsors and investigators as the study representative.
  • Conduct eligibility screening interviews by phone or in person.
  • Schedule study-patient appointments and send reminders by phone, letter, or email as appropriate.
  • Conduct protocol-required study-patient visits, including screening and follow-up visits, data collection and entry, specimen collection, and other study activities.
  • Communicate clinical trial status to management and staff through meetings and a tracking system, and maintain related records.
  • Create and update paper and electronic study-patient records.
  • Participate in recruitment and retention activities as needed, including calling potential participants and occasional outreach.
  • Attend required trainings, staff meetings, and in-services.
  • Assist laboratory personnel with specimen processing and shipping as needed.
  • Attend Investigator Meetings for new trials when assigned.

Benefits

  • Employer-sponsored health insurance, with BCBS HMO, PPO, and PPO Select plans.
  • BCBS dental insurance.
  • BCBS vision insurance.
  • Three weeks of paid vacation and one week of personal time.
  • 12 accrued sick days per year.
  • 10 paid holidays, including Juneteenth.
  • PTO Exchange, allowing employees to turn unused PTO into liquid assets.
  • 401(k) program with up to a 5% employer match after 90 days.
  • Employer-paid basic life insurance valued at one times annual salary.
  • Voluntary life and AD&D insurance.
  • Short-term and long-term disability coverage.
  • Pre-tax commuter and parking benefit account.
  • Flexible Spending Accounts for healthcare and dependent care.
  • Tuition reimbursement and student loan forgiveness programs, including NHSC and PSLF.
  • Employee Assistance Program with five employer-paid counseling sessions.
  • 50% discount at Brown Elephant Resale Shops and discounts at local businesses.
  • Continuous learning opportunities and professional development.
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