Baylor University Medical Center
Clinical Research Coordinator I
Baylor University Medical Center, Austin, Texas, United States, 78701
Clinical Research Coordinator 1
The Clinical Research Coordinator 1 helps Principal Investigators (PI) with clinical trials. This includes all trial phases, from pre-study to closure, following federal, state, and Institutional guidelines. This position will learn to assist on complex studies and seek guidance from senior roles when needed. Essential Functions of the Role: Implements various protocols for assigned research projects with appropriate departments. Interacts with PIs, clinical managers, and supervisors. Creates, facilitates, or executes various project workflows based on clinical trial protocol needs. Examples include providing in-service education for healthcare professionals and working with Pharmacy to ensure smooth project flow. Ensures appropriate billing mechanisms are in place for research charges. Requires familiarity with research study budgets. 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. Prepares Institutional Review Board (IRB) materials for protocol amendments. Submits Investigational New Drug (IND) Safety forms. Ensures all study documents are complete. Retains records 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 to ensure research studies are accurate, consistent, and have integrity. 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. Qualifications: Education - Bachelor's or 4 years of work experience above the minimum qualification Experience - Less than 1 Year of Experience
The Clinical Research Coordinator 1 helps Principal Investigators (PI) with clinical trials. This includes all trial phases, from pre-study to closure, following federal, state, and Institutional guidelines. This position will learn to assist on complex studies and seek guidance from senior roles when needed. Essential Functions of the Role: Implements various protocols for assigned research projects with appropriate departments. Interacts with PIs, clinical managers, and supervisors. Creates, facilitates, or executes various project workflows based on clinical trial protocol needs. Examples include providing in-service education for healthcare professionals and working with Pharmacy to ensure smooth project flow. Ensures appropriate billing mechanisms are in place for research charges. Requires familiarity with research study budgets. 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. Prepares Institutional Review Board (IRB) materials for protocol amendments. Submits Investigational New Drug (IND) Safety forms. Ensures all study documents are complete. Retains records 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 to ensure research studies are accurate, consistent, and have integrity. 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. Qualifications: Education - Bachelor's or 4 years of work experience above the minimum qualification Experience - Less than 1 Year of Experience