Shift: 8AM-5PM

　　Department: Baylor Research Institute for Rehabilitation

　　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

　　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.

　　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.

　　BENEFITS

　　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

　　QUALIFICATIONS

　　EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification

　　EXPERIENCE - 1 year of patient facing research experience

　　GCP experience, EMR experience preferred

　　As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.