Clinical Research Coordinator II

The Clinical Research Coordinator works under the supervision of Clinical Research Manager and in collaboration with all organization medical services to coordinate clinical research activities and the clinical information systems database. Perform multiple and varied tasks critical to the management of clinical research studies. Handle all basic clinical research study activities and conduct studies following all GCP/ICH guidelines, HIPAA requirements and Mosaic Life Care standard operating procedures.

• Implement clinical research protocols and study procedures while ensuring compliance with sponsor, FDA, ICH/GCP, HIPAA, and institutional requirements.
• Coordinate and oversee all phases of assigned clinical research studies, including study initiation, enrollment, maintenance, and close-out activities.
• Lead informed consent discussions and ensure participants demonstrate understanding of study requirements, risks, and benefits.
• Develop, maintain, and oversee accurate and complete study-specific source documents, regulatory binders, tracking logs, and organizational tools to ensure regulatory compliance and audit readiness.
• Identify, evaluate, document, and report participant progress, adverse events, protocol deviations, and safety concerns, by escalating issues appropriately to investigators and leadership.
• Serve as a subject matter expert in protocol interpretation and application to investigators and research caregivers by providing guidance on protocol requirements, study operations, and regulatory compliance.
• Perform and oversee study-related clinical procedures, participant assessments, collection of vital signs, ECGs, specimen collection, and other protocol-related activities.
• Ensure accurate and timely entry of study data, completion of case report forms, resolution of queries, and maintenance of electronic data capture.
• Implement recruitment and retention strategies to achieve enrollment goals, including screening and enrolling potential research participants according to protocol-specific inclusion and exclusion criteria.
• Ensure accurate interpretation and application of study protocols, procedures, and eligibility requirements.
• Collaborate in the development of recruitment and pre-screening materials and lead the informed consent process to ensure participant understanding and regulatory compliance.
• Monitor, evaluate, document, and report adverse events, serious adverse events (SAEs), protocol deviations, and other safety concerns in accordance with study protocols, sponsor requirements, and regulatory guidelines. Analyze clinical data and participant outcomes to identify potential adverse events and promptly communicate findings to investigators and study leadership to support participant safety and regulatory compliance.
• Develop, maintain, and oversee accurate and complete study-specific source documents, regulatory binders, tracking logs, and organizational tools. Ensure all participant observations, procedures, and study-related data are documented in accordance with protocol requirements, sponsor expectations, Good Clinical Practice (GCP) standards, and regulatory requirements to support compliance, data integrity, and audit readiness.
• Mentor and train new research staff and Clinical Research Coordinator I team members on study procedures, regulatory requirements, and departmental workflows.
• Collaborate with sponsors, CROs, monitors, laboratories, investigators, and research partners to coordinate study activities, communicate study progress and outcomes, resolve operational challenges, and ensure compliance with study protocols and regulatory requirements
• Utilize and optimize clinical research software systems and electronic platforms to enhance study workflow, operational efficiency, and data integrity. Ensure accurate and timely completion of Case Report Forms (CRFs), Electronic Data Capture (EDC) entries, and query resolution in accordance with study protocols, sponsor requirements, and departmental standards. Apply advanced knowledge of study requirements and independent judgment to support data quality, protocol compliance, and successful study execution.
• Other Duties as assigned.

Education

• Associate's Degree - Successful completion of formal/clinical training program(s), such as those required of registered nurses, licensed practical nurses, CNAs, emergency medical technician, R.T., and certified medical assistants or equivalent job experience - Required

Work Experience

• 2 Years - Clinical experience involving patient care in a healthcare environment - Required

Licenses and Certifications

• Certified Clinical Research Coordinator (CCRC) - Required Upon Hire

Travel Requirements

• Must be able to travel between various system facilities and off-site locations as needed- Required

Essential Technical/Motor Skills

• Ability to handle confidential and sensitive information.
• Ability to manage multiple projects and priorities in diverse locations, settings, and shifts. Knowledge of computer systems, including Excel, PowerPoint, and Word.

Interpersonal Skills

• Ability to function independently without close supervision, and to consistently exercise discretion and the highest level of good clinical and other professional judgment.
• Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.
• Ability to effectively devote keen and acute attention to detail.
• Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).
• Strong written and verbal communication skills as well as strong interpersonal skills.
• Strong self-motivation skills and the ability to be a “self-starter,” coupled with the capability to work as a team player, as well as independently, while simultaneously managing a variety of clinical research study related projects.
• Ability to meet and satisfy flexible, dynamic work schedules and be “on-call” if necessary.
  

Essential Physical Requirements

• Ability to be ambulatory most of workday
• Ability to lift / transfer / carry a minimum of 25 pounds without difficulty
• Ability to lift, push, manipulate equipment and subjects which requires strength, gross motor and fine motor coordination.
• Ability to perform CPR and venipuncture.
• Ability to stand or sit for long periods of time.

Essential Mental Abilities

• Originating/developing complex processes, procedures, services, and/or ideas in new, undefined areas.
• Applies independent thinking in order to guide the following work directions, understanding instructions, grasping work processes, and assimilating information into meaningful patterns of action.
• Ability to interpret data and manipulate numbers.
• High degree of independence.

Essential Sensory Requirements

• Fine motor skills.
• Eye/hand coordination.
• Visual, hearing

Exposure to Hazards

• Blood/Body fluids, hazardous chemicals, hazards associated with driving a vehicle.

Other Skills and Abilities