Clinical Research Coordinator 1 Jobs

Shift: 8AM-5PM

Location: 3535 Worth St, Dallas, 75246

Department: Surgical Research

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

• 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.
• 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.
• Performs research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
• Conducts and coordinates study-monitoring visits. Conducts audits and quality checks of research studies to check the accuracy, integrity and consistency of research studies.
• 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.
• Obtains knowledge of departmental functions through reading literature, attending workshops, seminars and conferences and participating in professional organizations.

KEY SUCCESS FACTORS

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

BENEFITS

Our competitive benefits package includes the following.

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

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, Bachelor's in Biology or Public Health preferred

- EXPERIENCE - Less than 1 Year of Experience

• Experience in consenting, enrolling and screening patients