JOB SUMMARY

The Clinical Research Coordinator I 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.
• Strong written and oral communication skills. Provide PIs with concise and clear email communication.
• Strong critical thinking skills and foundational research knowledge
• Exceptional computer skills, including Microsoft Office.
• Ability to manage time reactive projects in order to meet deadlines.
• Detail oriented and ability to multi-task in a fast paced environment with standing priorities.
• Exceptional ability to establish and maintain effective working relationships.
• Travel to McKinney clinic and potential travel to Frisco and Dallas
• Phlebotomy experience required for this role
• CCRC certification preferred
• Strong ability to establish and maintain effective working relationships with PIs, sponsors and colleagues. Meet with PIs regularly (as appropriate) for study questions, obtain signatures and complete required research documentation.
• 1 year of coordinator experience highly preferred

BENEFITS

Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include:

• 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