Clinical Research Coordinator II

Mosaic Life Care•Saint Joseph, MO

15h

About The Position

The Clinical Research Coordinator works under the supervision of the Clinical Research Manager and in collaboration with the organization’s medical services to coordinate clinical research activities and the clinical information systems database. The role performs varied tasks critical to managing clinical research studies, handles basic study activities, and conducts studies in accordance with GCP/ICH guidelines, HIPAA requirements, and Mosaic Life Care standard operating procedures. The coordinator oversees assigned studies from initiation through close-out, including participant recruitment, enrollment, consent, study procedures, safety monitoring, documentation, and data management. The position also provides protocol and regulatory guidance to investigators and research caregivers, mentors newer research staff, and works with sponsors, CROs, monitors, laboratories, investigators, and research partners. Travel between system facilities and off-site locations is required as needed. Mosaic Life Care is a health care system in northwest Missouri focused on holistic patient needs and providing care at the right time and place. It describes its vision as transforming community health by being a life-care innovator.

Requirements

Associate's degree and successful completion of a formal clinical training program, such as training for registered nurses, licensed practical nurses, CNAs, emergency medical technicians, radiologic technologists, or certified medical assistants, or equivalent job experience.
Two years of clinical experience involving patient care in a healthcare environment.
Certified Clinical Research Coordinator (CCRC) certification required upon hire.
Ability to handle confidential and sensitive information.
Knowledge of computer systems, including Excel, PowerPoint, and Word.
Ability to manage multiple projects and priorities across diverse locations, settings, and shifts.
Ability to work independently without close supervision and exercise discretion and sound professional judgment.
Ability to adapt quickly to a wide variety of dynamic therapeutic areas of medicine.
Strong attention to detail and ability to multitask under changing circumstances.
Strong written, verbal, and interpersonal communication skills.
Self-motivation and ability to work independently and as part of a team while managing multiple research projects.
Ability to meet flexible, dynamic work schedules and be on-call if necessary.
Ability to be ambulatory for most of the workday; lift, transfer, or carry at least 25 pounds; manipulate equipment and subjects; perform CPR and venipuncture; and stand or sit for long periods.
Ability to develop complex processes and procedures, think independently, understand instructions and work processes, interpret data, and manipulate numbers.
Fine motor skills, eye-hand coordination, and visual and hearing abilities.
Ability to work around blood and body fluids, hazardous chemicals, and hazards associated with driving a vehicle.

Responsibilities

Implement clinical research protocols and procedures in compliance with sponsor, FDA, ICH/GCP, HIPAA, and institutional requirements.
Coordinate and oversee assigned clinical research studies through initiation, enrollment, maintenance, and close-out.
Lead informed consent discussions and ensure participants understand study requirements, risks, and benefits.
Develop and oversee study-specific source documents, regulatory binders, tracking logs, and organizational tools to support regulatory compliance and audit readiness.
Identify, evaluate, document, and report participant progress, adverse events, protocol deviations, and safety concerns; escalate issues appropriately.
Provide investigators and research caregivers with guidance on protocol interpretation, study operations, and regulatory compliance.
Perform and oversee study-related clinical procedures and participant assessments, including vital signs, ECGs, and specimen collection.
Ensure timely and accurate study data entry, case report form completion, query resolution, and maintenance of electronic data capture systems.
Implement recruitment and retention strategies, screen potential participants, and enroll eligible participants according to protocol criteria.
Interpret and apply study protocols, procedures, and eligibility requirements accurately.
Collaborate on recruitment and pre-screening materials and lead informed consent processes.
Monitor, evaluate, document, and report adverse events, serious adverse events, protocol deviations, and other safety concerns in accordance with protocols and regulatory requirements.
Analyze clinical data and participant outcomes for potential adverse events and communicate findings promptly to investigators and study leadership.
Document participant observations, procedures, and study data according to protocol, sponsor, GCP, and regulatory requirements.
Mentor and train new research staff and Clinical Research Coordinator I team members on study procedures, regulatory requirements, and departmental workflows.
Coordinate study activities with sponsors, CROs, monitors, laboratories, investigators, and research partners; communicate progress and outcomes, resolve operational challenges, and support compliance.
Use and optimize clinical research software and electronic platforms to improve workflow, operational efficiency, and data integrity; apply independent judgment to support data quality and study execution.
Travel between system facilities and off-site locations as needed.
Perform other duties as assigned.