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Cincinnati Children’s Hospital and Medical Center

Pediatric hospital, research, and medical education

Clinical Research Coordinator 2 - Bone Marrow Transplantation

Clinical Research OperationsPosted on Nov 11
Full-timeOhio, USA$24.46 - $28.53In-person

About the Job

Requirements

  • A high school diploma or equivalent and 2 years of work experience in a related job discipline are required; alternatively, a bachelor's degree in a related field is preferred.
  • Demonstrate awareness of federal regulations, state and local law, Good Clinical Practice, International Council for Harmonisation guidelines, and institutional policies governing ethical research with human participants.
  • Identify regulatory activities that need to be completed and take initiative to complete them.
  • Maintain awareness of active study status and identify potentially eligible participants.
  • Conduct protocol-specific pre-consent screening procedures to determine participant eligibility.
  • Complete case report forms and source documentation according to applicable human research guidelines.
  • Review case report forms for completeness, accuracy, and compliance with Good Clinical Practice.
  • Enter data into auditable databases or electronic data-capture systems.
  • Perform quality checks to ensure data accuracy and review reports, tables, and listings.

Responsibilities

  • Coordinate studies by preparing personnel and materials, protocols, informed consents, amendments, and other documents for institutional review board and sponsor review.
  • Assemble laboratory kits and supplies; collect and label samples; deliver or process samples according to protocol, operations manuals, standard operating procedures, and work instructions; and ensure specimens are logged, handled, and stored properly.
  • Follow directions from the clinical research coordinator or other project staff, assist staff and coordinators with study implementation, maintain supply and equipment inventories, operate standard laboratory and research equipment as applicable, and troubleshoot erroneous results or equipment problems.
  • Coordinate and participate in assembling regulatory materials; maintain accurate written and electronic records; assist with audit-readiness reviews; maintain protocol-specific standard operating procedures and regulatory correspondence; report ethical or regulatory concerns to a supervisor promptly; document regulatory activities and maintain regulatory binders according to institutional and division procedures; and seek research education opportunities.
  • Plan and execute study visits, provide participant instructions and reimbursement, approach participants and families professionally, review consent forms and allow time for consideration, and complete informed-consent procedures according to Good Clinical Practice and applicable policies.
  • Communicate with participants' clinical teams about study participation as required by protocols or operations manuals; 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 the appropriate research team member; track study-related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical teams, managers, and other institutions; maintain relationships and rapport with participants; and provide input to division discussions about research studies.
  • Participate in meetings and activities aimed at improving organizational performance by recommending improvements to study conduct.
  • Maintain internal record-keeping systems with study team members, verify source documentation, support clinical research data management, and address data queries from data managers, project statisticians, and sponsors.

Desired Qualifications

  • A bachelor's degree in a related field.

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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