Clinical Research Coordinator

Default Work Shift:

Varies (United States of America)

Hours:

0

Salary range:

$

Schedule:

Per Diem

Shift Hours:

8 Hour employee

Department:

Research-Cardiology

Job Objective:

Coordinates and implements clinical research activities.

Job Description:

Education:

Required: Bachelor’s degree in healthcare and/or related field; completion of following CITI Program courses within 30 days of hire: Good Clinical Practice (GCP) Course, Clinical Research Coordinator Foundations Course, Clinical Research Coordinator Advanced Course; courses must be renewed in accordance with institutional policy

Preferred: Master’s degree

Licensure/Certification:

Preferred: ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility

Experience:

Required: Three (3) years current experience in acute care hospital, medical center, health system or related industry

Preferred: Previous experience with clinical trials

Reports To: Manager-Research and Clinical Trials Supervises: N/A Ages of Patients: Adult, Geriatric Blood Borne Pathogens: Moderate Potential

Skills, Knowledge, Abilities:

Ability to collect, analyze and disseminate data, Ability to coordinate multiple projects, Ability to create and maintain positive interpersonal relations with peers, staff, leaders and vendors, Ability to prioritize tasks and manage time efficiently to meet deadlines, Ability to use Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and other relevant software applications, Ability to work independently and as a team member, Knowledge of good clinical practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects, Understanding of relevant technologies and tools pertinent to the job role, Written and verbal communication skills

Essential Responsibilities

1. Demonstrates compliance with Code of Conduct and compliance policies and takes action to resolve compliance questions or concerns and report suspected violations. 2. Recruits, educates, consents, schedules, and completes follow-up with patients/subjects. 3. Participates in the design, planning and conduct of clinical trials program and clinical research projects. 4. Performs pre-investigation, initiation and periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established and followed. 5. Monitors subject records for quality, data integrity and compliance with regulations and organization’s standard operating procedures (SOP). 6. Assists in writing and/or auditing clinical reports. 7. Assists in developing protocols, case report forms, and informed consent documents. 8. Works closely and acts as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members. 9. Manages the negotiation and monitoring of budgets and contracts; formulates study budgets utilizing the protocol, manuals, study plan and resource needs assessment for the study; develops and supports the development of tools and training to aid in the development of study budgets, coverage analysis, tracking of invoiceable term items and research billing. 10. Performs clinical site activities (regulatory issues, patient accrual, patient scheduling and care coordination, data capture and monitoring, adverse events reporting). 11. Develops sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership. 12. Develops or contributes to the development of SOPs, best practices, tools, processes and training to enhance safety and compliance with federal, local and institutional regulations/guidelines. 13. Manages tracking and reporting Serious Adverse Events (SAEs) and Adverse Events (AEs). 14. Works with physicians and leadership to develop and implement client trials and research programs; carries out key activities in evaluating, initiating, operationalizing and conducting clinical trials. 15. Works closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials. 16. Prepares and presents materials to Institutional Review Board (IRB); investigates and resolves problems and complaints; develops corrective and preventative action plans. 17. Develops educational/promotional materials to educate patients on available programs and clinical trials; develops and maintains a formal mechanism to ensure that information about the availability of clinical trials is provided to patients. 18. Works to accrue and monitor cases enrolled in program and clinical trials; reports to governing Committee. 19. Coordinates performance improvement activities as they relate to clinical trials and research. 20. Provides support to investigators and maintain screening, enrollment, compliance, statistics on program and trials. Involved in planning long or short term objectives that support research program. 21. Develops and implements Education Program for the community, including materials and lectures. 22. Performs other duties as assigned.