Clinical Research Coordinator I - IGM

About the Role

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 activities, launch activities, day-to-day management of a study, and study closure activities.

Responsibilities

• Recruits, consents, and enrolls subjects according to ICH/GCP regulations and institutional IRB, federal, and state regulations; acts as a patient/family advocate.
• Ensures subjects meet inclusion/exclusion criteria; alerts the investigator of safety concerns, protocol deviations, or premature study termination requests.
• Collects and manages research data and subject information; maintains accurate data collection, including laboratory analytical procedures.
• Prepares and processes human specimens for research studies, including blood, urine, and other samples as needed. Performs CLIA-waived laboratory assessments, which may require evening and weekend hours.
• Completes screening sheets and recruitment logs.
• Creates source documents to facilitate systematic data collection and protocol execution.
• Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
• Adheres to departmental quality control guidelines.
• Completes Case Report Forms (CRFs) as instructed by the sponsor and ensures they are ready prior to monitoring visits.
• Maintains regulatory binder and documents.

Requirements

• 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.

Skills

• Understanding of medical terminology and clinical research preferred.
• 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 and self-directive.
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Experience

Previous experience in clinical research or a healthcare-related field preferred.

Physical Requirements

• 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 0-40 lbs, machinery, patient equipment, pushing/pulling 0-100 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).