Department: Cardiology

Location: Plano Heart Hospital

Shift: 8AM-5PM

JOB SUMMARY

The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines. This position will learn to assist Principal Investigators on more complex studies and seek guidance from more senior roles when needed.

ESSENTIAL FUNCTIONS OF THE ROLE

• Implements various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors.
• Creates, facilitates, and/or executes a variety of different project workflows based on the needs of the clinical trial protocol. Examples of workflows include, providing in-service education for healthcare professionals and working with Pharmacy to ensure a smooth project flow.
• Ensures that appropriate billing or charging mechanisms are in place for research charges related to research studies. Requires familiarity with research study budgets and provides feedback on budgets for new clinical trials.
• Performs research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
• Partners and coordinates with regulatory compliance including preparing Institutional Review Board (IRB) materials for approval of protocol amendments and submitting Investigational New Drug (IND) Safety forms. Ensures that all study documents are complete and that records are retained per federal, state and institutional standards.
• Obtains knowledge of departmental functions through reading literature, attending workshops, seminars and conferences and participating in professional organizations.
• Conducts and coordinates study-monitoring visits. Conducts audits and quality checks of research studies to check the accuracy, integrity and consistency of research studies.

KEY SUCCESS FACTORS

• Research certification or other certifications per specialty area preferred.
• Proven written and oral communication skills.
• Exceptional computer skills, including Microsoft Office.
• Ability to manage time reactive projects in order to meet deadlines.
• Exceptional ability to establish and maintain effective working relationships.

BENEFITS

Our competitive benefits package includes the following.

• Immediate eligibility for health and welfare benefits
• 401(k) savings plan with dollar-for-dollar match up to 5%
• Tuition Reimbursement
• PTO accrual beginning Day 1

Note: Benefits may vary based upon position type and/or level