Clinical Research Coordinator – Cardiology

This is an entry level position that provides coordination and administrative support for clinical research projects, specifically Cardiology, with supervision.  This position will  perform data entry in EDC, Redcap, CTMS and resolve simple queries, data extraction from medical record to study forms, maintain research records including screening/enrollment logs and electronic regulatory files independently. May participate in recruitment, consent, device accountability follows ups and monitoring visits under supervision.

Responsibilities

Clinical Coordination

• 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.
• May complete P-card reimbursement to patients.
• Subject visit billing and tracking of invoiceable items.
• Assist with preparation for and present at study initiation meetings, audits, and monitoring visits.
• Performs simple study procedures with accuracy.
• May obtain informed consent from subject.

Data Coordination

• Enters data to complete forms (CRFs) on paper, databases, or EDCs.
• Demonstrates ability to resolve simple queries.
• Explains how to utilize information from the EMR and study databases.
• Demonstrates the ability to complete simple data collection during study visits.
• Demonstrates the ability to document data in accordance with ALCOA-C principles.
• Administer 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.

Regulatory Coordination

• Uses proper documentation techniques as outlined in the ICH-GCP guidelines.
• May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.)  as outlined in the ICH-GCP guidelines.
• Assists Regulatory manager in submission and management of IRB applications.
• Assists with identification of Adverse Events (AEs), Serious Adverse Events (SAEs), UP and understands how to report appropriately.

Administrative Responsibilities

• Provide other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.)
• May communicate with study participants such as sending study correspondence via mail or email.
• May schedule subjects for research visits and FU appointments.
• May check study calendar for completion of study procedures.
• May manage study supply inventory.
• May utilize documents and systems to track recruitment and retention of participants.
• Participates in regular study meetings.
• Properly completes payment forms and pays participants accordingly.
• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to Unersity and Federal guidelines.
• Provide other administrative support for study activity including management of subject reimbursement and payment.
• 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 resolved.

Training

• CITI, GCP, HIPAA.
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Will to learn about the disease process per program.
• Attends and participates in all training assigned to this level.
• Please note that specific responsibilities may vary based on the needs of your unit or team. Certain units may require a greater focus on clinical, data, regulatory, or other specific needs. The role of a Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.

Functional Knowledge

• Knowledge of the general research process and medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Problem Solving

• Utilizes analytical skills to solve simple problems based on guidelines, protocols, and procedures.

Decision Making/ Autonomy

• Works under direct supervision to ensure tasks are carried out per guidelines and regulation.

Communication Skills

• Shares information and confirmation of data.
• Performs other responsibilities as needed.

Minimum Qualifications

• Bachelor's degree in a specific research field or equivalent in education and experience, plus up to years of related experience.

Other Requirements

• Basic knowledge and understanding of clinical research processes and regulations and understanding the role of the CRC in a clinical research study.
• Participation in Medical Surveillance Program.
• Must successfully complete systems training requirements.