Clinical Research Coordinator I - Cardiology (CARE)

Responsibilities

• May create a recruitment plan that addresses the needs of the study population.
• Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.
• Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC.
• Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
• Understands protocol structure and how to interpret study requirements to ensure study compliance.
• Understands proper documentation techniques as outlined in the ICH-GCP guidelines.
• Completes P-card reimbursement to patients.
• Processes subject visit billing and tracking of invoiceable items.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Obtains informed consent from subject.
• Conducts all startup, active implementation, and closeout activities.
• Affirms the ability to anticipate and mitigate the potential for protocol non-compliance.
• Traits subject concerns and issues appropriately.
• Performs moderately complex study procedures with accuracy.
• Enters data to complete forms (CRFs) on paper, databases, or EDCs.
• Demonstrates ability to resolve moderately complex queries (e.g., data error changed numerous values in EDC).
• Explains how to utilize information from the EMR and study databases.
• Demonstrates the ability to complete moderately complex data collection during study visits.
• Demonstrates the ability to document data in accordance with ALCOA-C principles.
• Administers surveys and questionnaires.
• Demonstrates ability to perform concomitant medications abstraction.
• Builds patient research study charts.
• Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.
• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles.
• Creates and manage databases.
• Uses proper documentation techniques as outlined in the ICH-GCP guidelines.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Assists Regulatory manager in submission and management of IRB applications.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and understands how to report appropriately.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.
• Manages study supply inventory.
• Utilizes documents and systems to track recruitment and retention of participants.
• Participates in regular study meetings.
• Provides logistic and regulation guidance to entry level employees on Federal and University policy and guidelines.
• Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolve.

Training

• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Attends and participates in all training assigned to this level including CITI, GCP, HIPAA.
• Understands the disease process per program.
• Participates in trainings specifically for maintaining certification as a Clinical Research Professional.
• Provides training and mentorship for CRC clinical research staff on communication and teamwork best practices.
• Attends and participates in all training assigned to this level.

Competency

• Functional Knowledge: Demonstrates a strong understanding of the research subject matter specific to their role on the team.
• Problem Solving: Analyzes moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.
• Decision Making/Autonomy: Carries out research projects per guidelines and regulation with limited supervision, collaborating both independently and with the Principal Investigator (PI) and Clinical Research Manager. Requires a moderate degree of initiative and independent judgment.
• Communication Skills: Summarizes and explains research information to others effectively.

Other Responsibilities

• As Assigned.