Clinical Research Coordinator - Emergency Medicine

Overview

Manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures.

These elements include but are not limited to: start-up activities, launch activities, day-to-day management of a study and study closure activities.

• Recruit, consent, and enroll subjects according to ICH/GCP regulations and institutional IRB, federal and state regulations.
• Answer questions related to protocol procedures and act as patient/family advocate.
• Ensure subjects meet inclusion/exclusion criteria and report safety concerns, protocol deviations, or premature study termination requests.
• Collect and manage research data and subject information, maintaining accurate data collection of all study data including laboratory analytical procedures.
• Prepare and process human specimens, collecting blood, urine, and other samples as needed according to skill level and certifications.
• Perform CLIA waived laboratory assessments.
• Complete screening sheets and recruitment logs and create source documents to facilitate systematic data collection and protocol execution.
• Collaborate, coordinate, and schedule subject study visits with other hospital services and the PI/sub-I.
• Adhere to departmental quality control guidelines and complete Case Report Forms (CRFs) as instructed by the sponsor, ensuring CRFs are completed prior to monitoring visits.
• Maintain regulatory binder and documents.

• Associate's Degree or equivalent certification/experience required (Bachelor's Degree preferred).
• Required certifications: CNA, PCA, LPN, MA, or equivalent education/experience.
• 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, squat/kneel; frequently: bend/twist, biohazard waste, blood and/or bodily fluids, chemicals/medications, communicable diseases and/or pathogens, lifting/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, flexing/extending of neck, hand use: grasping, gripping, turning, hearing acuity, interpreting data, peripheral vision, problem solving, repetitive hand/arm use, seeing – far/near.

EOE M/F/Disability/Vet