Baylor Scott & White Health
Clinical Research Coordinator II
Baylor Scott & White Health, Plano, Texas, us, 75086
Shift: 8AM-5PM
Department: Cardiology
Location: Plano Hear Hospital
JOB SUMMARY
The Clinical Research Coordinator 2 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.
ESSENTIAL FUNCTIONS OF THE ROLE
Reviews new protocols and other materials provided by Study Sponsors, and provides input to the PIs and clinical managers, as applicable, regarding clinical and research issues in order to establish financial and clinical feasibility.
Coordinates the 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.
Reports to the Institutional Review Board (IRB), completing IRB review reports and assisting with drug accountability.
Develops research study budgets for new clinical trials and assists in the completion of all applicable research billing compliance procedures.
Coordinates study-monitoring visits. Completes and submits monthly invoices for applicable patient care charges covered by funded research studies.
Participates in data testing, writing and submitting manuscripts and abstracts for publication, as appropriate.
Develops, implements and administers Clinical Research policies and procedures.
Unites with quality audits.
KEY SUCCESS FACTORS
Research certification and other certifications per specialty area preferred.
Proven written and oral communication skills.
Proven 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.
Ability to autonomously operationalize and coordinate large or complex studies from start to finish.
Ability to autonomously work across functional departments within BSWRI.
Proven critical thinking and problem-solving skills; ability to troubleshoot study challenges.
Ability to work within a team, including training of junior staff.
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 - 2 Years of Experience
CERTIFICATION/LICENSE/REGISTRATION -
Cert Clinical Research Assoc (CCRA), Cert Clinical Research Coord (CCRC), CCRP-Cert Clnl Research Prof (CCRP-RES): Research Certification and/or certification that pertains to particular work area must be obtained within one year.
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.
Department: Cardiology
Location: Plano Hear Hospital
JOB SUMMARY
The Clinical Research Coordinator 2 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.
ESSENTIAL FUNCTIONS OF THE ROLE
Reviews new protocols and other materials provided by Study Sponsors, and provides input to the PIs and clinical managers, as applicable, regarding clinical and research issues in order to establish financial and clinical feasibility.
Coordinates the 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.
Reports to the Institutional Review Board (IRB), completing IRB review reports and assisting with drug accountability.
Develops research study budgets for new clinical trials and assists in the completion of all applicable research billing compliance procedures.
Coordinates study-monitoring visits. Completes and submits monthly invoices for applicable patient care charges covered by funded research studies.
Participates in data testing, writing and submitting manuscripts and abstracts for publication, as appropriate.
Develops, implements and administers Clinical Research policies and procedures.
Unites with quality audits.
KEY SUCCESS FACTORS
Research certification and other certifications per specialty area preferred.
Proven written and oral communication skills.
Proven 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.
Ability to autonomously operationalize and coordinate large or complex studies from start to finish.
Ability to autonomously work across functional departments within BSWRI.
Proven critical thinking and problem-solving skills; ability to troubleshoot study challenges.
Ability to work within a team, including training of junior staff.
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 - 2 Years of Experience
CERTIFICATION/LICENSE/REGISTRATION -
Cert Clinical Research Assoc (CCRA), Cert Clinical Research Coord (CCRC), CCRP-Cert Clnl Research Prof (CCRP-RES): Research Certification and/or certification that pertains to particular work area must be obtained within one year.
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.