Clin Rsch Coord II - General Pediatrics

Cincinnati Children's

1d•$24 - $29•Onsite

About The Position

The Clinical Research Coordinator II supports clinical research studies in General Pediatrics. The role assists with study coordination and conduct, including preparing study personnel and materials, assembling lab kits, collecting and handling specimens, maintaining supplies and equipment, and operating and troubleshooting standard research equipment as applicable. The coordinator follows the direction of clinical research leadership and supports other staff in implementing studies. The position helps identify and complete regulatory activities, maintain accurate study records and regulatory documentation, and support audit readiness. It also supports recruitment, enrollment, and retention by identifying potentially eligible participants, coordinating study visits, conducting protocol-specific screening, and carrying out the informed consent process in accordance with applicable policies and Good Clinical Practice. The coordinator communicates with participants, families, clinical teams, and research collaborators, and raises study issues to the appropriate team members. The role manages study data by completing and reviewing case report forms and source documentation, entering information into auditable databases or electronic data-capture systems, performing quality checks, and responding to data queries. The position is based at the Burnet Campus, with a day shift schedule of 40 hours per week.

Requirements

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

Nice To Haves

Strong interpersonal skills.
Interest in health equity, social justice, and community engagement.

Responsibilities

Assist with coordinating studies by preparing personnel and materials and preparing protocols, informed consents, amendments, and other documents for IRB and sponsor review.
Assemble lab kits and supplies; collect, label, log, handle, store, deliver, or process specimens according to study protocols and procedures.
Follow direction from clinical research coordinators and other project team members, and assist staff with study implementation.
Maintain inventory of supplies and equipment; operate standard laboratory and research equipment as applicable; troubleshoot and correct equipment problems or erroneous results.
Identify regulatory activities, coordinate and participate in assembling materials, maintain accurate written and electronic records, and support audit-readiness reviews and preparation.
Maintain protocol-specific SOPs, IRB and regulatory correspondence, regulatory documentation, and regulatory binders according to institutional and divisional procedures.
Maintain awareness of active studies and identify potentially eligible participants.
Coordinate, plan, and conduct study visits; provide participant instructions and reimbursement; conduct pre-consent screening; and complete informed consent according to protocol and applicable policies.
Communicate with participants’ clinical teams as indicated, document participants approached, screened, and enrolled, and raise recruitment and retention challenges and recommendations to study leadership.
Organize and file correspondence, refer study questions and issues to appropriate team members, maintain relationships with participants, and participate in research and organizational improvement discussions.
Complete case report forms and source documentation, review forms for completeness and accuracy, enter data into auditable databases or electronic data-capture systems, and maintain internal study records.
Perform data quality checks, review reports, tables, and listings, and support data management by addressing queries from data managers, statisticians, and sponsors.
Seek research education opportunities and report ethical or regulatory concerns to a supervisor in a timely manner.