Clinical Research Coordinator - Emergency Medicine

Job Description Summary

Manages elements of a clinical study to meet all protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Responsibilities include start‑up, launch, day‑to‑day study management, and study closure activities.

• Recruits, consents, and enrolls subjects in accordance with ICH/GCP regulations, IRB, and relevant federal and state regulations.
• Assesses inclusion and exclusion criteria and alerts investigators to safety concerns, protocol deviations, or premature study termination requests.
• Collects, manages, and maintains accurate research data, including laboratory analytical procedures.
• Prepares and processes human specimens (blood, urine, etc.) for research studies; performs CLIA waived laboratory assessments, as required.
• Completes screening sheets and recruitment logs.
• Creates source documents that facilitate systematic data collection and aid in protocol execution and management.
• Collaborates, coordinates, and schedules subject visits with hospital services, the PI, and sub‑investigators.
• Adheres to departmental quality control guidelines.
• Completes Case Report Forms (CRFs) as instructed by the sponsor and ensures CRFs are completed before monitoring visits.
• Maintains the regulatory binder and associated documents.

• Associate’s Degree, or equivalent certification or experience, required.
• Bachelor’s Degree preferred.

• CNA, PCA, LPN, MA, or equivalent education or experience, required.
• Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire, required.

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

Previous experience in clinical research or health care related field preferred.

Occasionally: cold temperatures, fumes/gases/vapors, loud noises, reaching above shoulder, squatting/kneeling.
Frequently: bending/twisting, biohazard waste, blood and bodily fluids, chemicals/medications, communicable diseases and/or pathogens, lifting and carrying (0–10 lbs, 11–20 lbs, 21–40 lbs), machinery, patient equipment, pushing/pulling (0–25 lbs, 26–40 lbs, 41–60 lbs, 61–100 lbs), sitting, standing, walking.
Continuously: audible speech, computer skills, decision making, depth perception, neck flexion/extension, hand use (grasping, gripping, turning), hearing acuity, data interpretation, peripheral vision, problem solving, repetitive hand/arm use, vision (far/near).

EOE M/F/Disability/Vet