Location: 3409 Worth St, Dallas, 75246
The Clinical Research Coordinator 1 will learn to assist 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.
ESSENTIAL FUNCTIONS OF THE ROLE
- Coordinates implementation of various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors, providing in-service education for healthcare professionals, and working with Pharmacy to ensure a smooth project flow.
- Assists in the development of research study budgets for new clinical trials, and helps ensure that appropriate billing or charging mechanisms are in place for research charges related to research studies.
- Assists and learns to coordinate research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
- Assists with regulatory compliance including assisting with 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. Learns to conduct audits of research studies to check the accuracy, integrity and consistency of research studies. Learns to coordinate study-monitoring visits.
KEY SUCCESS FACTORS
- Research certification or other certifications per specialty area preferred.
- Strong written and oral communication skills.
- Strong computer skills, including Microsoft Office.
- Ability to manage time sensitive projects in order to meet deadlines.
- Strong ability to establish and maintain effective working relationships.
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
- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
- EXPERIENCE - 2 Years of Experience