Clinical Research Coordinator I

About the role

The Center for Surgical Outcomes Research (CSOR) seeks an energetic and collaborative Clinical Research Coordinator (CRC) to join a multidisciplinary team of surgeons, biostatisticians, epidemiologists, research staff, and trainees. CSOR, part of the Center for Child Health Equity and Outcomes Research (CCHEOR) at the Abigail Wexner Research Institute at Nationwide Children’s Hospital, is a national leader in clinical and health services research focused on improving the delivery and outcomes of surgical care for children.

The CRC will manage elements of clinical studies in compliance with ICH/GCP guidelines and institutional standard operating procedures, including start-up, launch, day-to-day management, and study closure activities.

Responsibilities

• Recruit, consent, and enroll subjects according to ICH/GCP regulations, institutional IRB, federal and state regulations; act as a patient/family advocate.
• Ensure subjects meet inclusion/exclusion criteria; alert investigators to safety concerns, protocol deviations, or premature study termination requests.
• Collect and manage research data and subject information; maintain accurate data collection, including laboratory analytical procedures.
• Prepare and process human specimens (e.g., blood, urine) for research studies; perform CLIA-waived laboratory assessments, including evening/weekend hours as needed.
• Complete screening sheets, recruitment logs, and source documents to facilitate systematic data collection and protocol execution.
• Collaborate with hospital services and principal investigators to schedule subject study visits.
• Adhere to departmental quality control guidelines.
• Complete Case Report Forms (CRFs) as instructed by the sponsor and ensure timely submission prior to monitoring visits.
• Maintain regulatory binders and documentation.

Requirements

• Associate's Degree, or equivalent certification/experience (required). Bachelor's Degree (preferred).
• Certification as CNA, PCA, LPN, MA, or equivalent education/experience (required).
• Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire (required).
• Previous experience in clinical research or a healthcare-related field (preferred).

Skills

• Understanding of medical terminology and clinical research.
• Working knowledge of PCs, word processing, and data management software.
• Demonstrated analytical skills with accuracy and attention to detail.
• Excellent verbal and written communication skills.
• Goal-oriented, self-directive, and strong organizational/interpersonal skills.
• Ability to actively participate as a team player.

Physical Requirements

• Occasionally: Cold temperatures, fumes/gases/vapors, loud noises, reaching above shoulder, squatting/kneeling.
• Frequently: Bending/twisting, biohazard waste, blood/bodily fluids, chemicals/medications, communicable diseases/pathogens, lifting/carrying 0–40 lbs, machinery, patient equipment, pushing/pulling 0–100 lbs, sitting, standing, walking.
• Continuously: Audible speech, computer skills, decision-making, depth perception, flexing/extending neck, hand use (grasping, gripping, turning), hearing acuity, interpreting data, peripheral vision, problem-solving, repetitive hand/arm use, seeing (far/near).