Clinical Research Coordinator II

JOB DESCRIPTION

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.