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
- Conducting patient facing clinical research visits for various interventional and complex pulmonary clinical trials.
- Manage assigned clinical trials during all phases of study execution including Study Operationalizing (source document creation, workflow, managing inventory, etc), Study Enrollment & Follow Up (executing patient visits, managing data queries, etc), and Study Closure.
- Ensures that appropriate billing or charging mechanisms are in place for research charges related to research studies. Requires familiarity with research study budgets.
- 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 in-service trainings with Physicians, attending workshops, seminars, or participating in investigator meetings when they occur.
- Conducts and coordinates study-monitoring visits. Answer audits findings and quality assurance findings of assigned research studies to check the accuracy, integrity, and consistency of research studies.
- Learns how accurately complete pulmonary specific assessments including Pulmonary Function Testing, Six-Minute Walk Test, Standardized Questionnaires, etc.
KEY SUCCESS FACTORS
- Research certification or other certifications per specialty area preferred
- Phlebotomy and Lab skills preferred
- Spanish Speaking Skills beneficial but not essential
- Independence
- Proven written and oral communication skills.
- Familiarity and Proficiency with Microsoft Suite (Excel, Word, Teams, Outlook, SharePoint)
- Ability to Adapt to changes in assigned projects, tasks, and timelines
- Ability to manage time reactive projects in order to meet deadlines.
- Exceptional ability to establish and maintain effective working relationships.
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
QUALIFICATIONS- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
- EXPERIENCE - Less than 1 Year of Experience