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Cincinnati Children’s Hospital and Medical Center

Pediatric hospital, research, and medical education

Clinical Research Coordinator 2 - Emergency Medicine

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeAustin, TX, USAIn-person

About the Job

Requirements

  • A high school diploma or equivalent is required.
  • At least 2 years of work experience in a related job discipline, or an equivalent combination of education and experience, is required.
  • An associate degree, vocational training, apprenticeship, or equivalent may be required.

Responsibilities

  • Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments, and other documents for review by the Institutional Review Board and sponsor.
  • Assemble laboratory kits and supplies; collect and label samples as instructed; deliver or process samples according to protocols, manuals of operations, standard operating procedures, or other work instructions; and ensure specimens are logged, handled, and stored properly.
  • Follow direction from clinical research coordinators and other research project staff, and assist staff and coordinators with study implementation.
  • Maintain supply and equipment inventory; operate standard laboratory and research study equipment when applicable; and troubleshoot and correct erroneous results or equipment problems.
  • Identify regulatory activities to complete and take initiative in completing them; coordinate and participate in assembling materials; and maintain accurate written and electronic records supporting clinical research activities.
  • Assist with audit-readiness records review and preparation, maintaining protocol-specific standard operating procedures and Institutional Review Board and regulatory correspondence, and documenting regulatory activities and maintaining regulatory binders in accordance with institutional and division procedures.
  • Demonstrate awareness of federal regulations, state and local law, Good Clinical Practice and International Council for Harmonisation guidelines, and institutional policies; report ethical or regulatory concerns to a supervisor in a timely manner; and seek research education opportunities.
  • Maintain awareness of active study status; identify potentially eligible participants; coordinate, plan, and conduct study visits; provide participant instructions and reimbursement; approach potential participants and families professionally; and conduct protocol-specified screening to determine eligibility.
  • Review consent forms with participants, allow time for consideration, and conduct informed consent according to Good Clinical Practice, institutional procedures, and applicable policies.
  • Communicate with participants’ clinical teams about study participation when indicated by the protocol or manual of operations, and document participants approached, screened, and enrolled in applicable tracking and electronic health systems.
  • Communicate recruitment and retention challenges to study leadership and recommend improvements.
  • Organize and file correspondence; refer study-conduct questions and issues to appropriate research team members; and maintain awareness of study-related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical teams, managers, and other institutions.
  • Maintain rapport and relationships with study participants; provide input to division discussions about clinical research studies; and participate in meetings and activities to improve organizational performance by recommending improvements to study conduct.
  • Complete case report forms and source documentation according to applicable human research guidelines; review case report forms for completeness, accuracy, and Good Clinical Practice compliance; and enter data into auditable databases or electronic data-capture systems.
  • Maintain internal record-keeping systems with study team members, ensure source documentation accuracy, perform data quality checks, review reports, tables, and listings, and support research project data management, including resolving queries from data managers, project statisticians, and sponsors.

About the Company

Cincinnati Children’s Hospital and Medical Center

Pediatric hospital, research, and medical education

Cincinnati Children’s Hospital Medical Center is a nonprofit academic medical center that provides pediatric care across the spectrum—from routine well-child visits to treatment of rare and complex illnesses—and serves as the Department of Pediatrics for the University of Cincinnati College of Medicine. Care is delivered by pediatric specialists in hospital and clinic settings, while researchers and educators translate findings into better treatments and train residents and fellows. It differentiates itself by combining patient care with university-backed pediatric research and education at scale, along with a commitment to equality and an inclusive environment for staff, patients, and families. Its goal is to improve child health by delivering high-quality care, advancing medical knowledge through research, and training the next generation of pediatric professionals.

Company size
10,001+
Company stage
Grant
Total funding
$18.4M
Headquarters
Cincinnati, OH
Founded
1883

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