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Posting Title Protocol Submission Coordinator,Cancer Ctr Clinical Research

Company: Meridian Health Services
Location: Hackensack
Posted on: June 12, 2018

Job Description:

Job ID 21029
Department Cancer Ctr Clinical Research
Site Hackensack University Medical Center
Job Location US-NJ-Hackensack
Position Type Full Time with Benefits
Standard Hours Per Week 40
Shift Day
Shift Hours 8 a.m. - 4:30 p.m.
Weekend Work No Weekends Required
On Call Work No On-Call Required

Overview

How have you impacted someone's life today? At Hackensack Meridian Health our teams are focused on changing the lives of our patients by providing the highest level of care each and every day. From our hospitals, rehab centers and occupational health teams to our long-term care centers and at-home care capabilities, our complete spectrum of services will allow you to apply your skills in multiple settings while building your career, all within New Jersey's premier healthcare system.

Responsibilities

The Protocol Submission Coordinator is responsible for overseeing the initial submission of Clinical Trial protocols to the designated Institutional Review Board. The Protocol Submission Coordinator is to coordinator multidepartment review of the protocols and troubleshoots any delays throughout the submission/activation process.1. Oversight of new Clinical Trial Protocol Submissions to the designated Institutional Review Board (IRB): a. Collection, Distribution and Completion of Regulatory Documentation for new Clinical Trial Projects from the Initial Feasibility through the IRB Approval phases. b. Completion of IRB submission application and associated forms/documentation. c. Review/Completion of Protocol Essential Documents (Informed Consent Form, Designee Form, etc.) and inclusion of Institution standardized language as developed by HackensackUMC legal. d. Coordinate with Clinical Trial Sponsors/Designees to expedite protocol submissions. e. Study entry into internal database and routing for Physician, Study Staff and Ancillary Department Review/Approvals.2. Completion of Study Submission Tracking Log for the development of Month department reporting metrics.3. Follow-Up with Research Team for study approvals/sign-offs.4. Facilitates the Review and Execution of Confidentiality Agreements, Material Transfer Agreements and Clinical Trial Agreements.5. Serve as a liaison between IRB, Research Staff and Clinical Trial Sponsors.6. Distribution of Approved Study Documentation (Trial Activation) to applicable staff.7. Entry of Clinical Trial Protocol into Department's electronic tracking software and Hospital EMR System.8. Troubleshoot and develop/implement solutions to Protocol IRB Submission delays.9. Assist with orienting new staff on their regulatory responsibilities.10. Work on special projects for Clinical Cancer Research Department as assigned by leadership.11. Maintains strong lines of communication with ancillary departments and outside vendors/parties.12. Adheres to standards identified in the Medical Center's Organizational Competencies.Working Conditions: Lifts a minimum of 5 lbs., pushes and pull a minimum of 10 lbs. and stands a minimum of 4 hours a day.

Qualifications

Education, Knowledge, Skills and Abilities Required: 1. Bachelor's Degree or 2 years experience with IRB submissions/clinical research.Education, Knowledge, Skills and Abilities Preferred: 1. Advanced Microsoft Office Skills (Excel, Word).2. Experience with Oncology and/or Research Preferred.3. Ability to Analyze Complex Situations and Identify Solutions.4. Ability to work effectively as a member of a team.5. Knowledge of medical/scientific terminology/concepts.6. Effective written and verbal communication skills; excellent interpersonal skills.7. Knowledge of Human Subject Research and applicable Procedures/Regulations pertaining to IRBs and Clinical Research.Licenses and Certifications Required: Licenses and Certifications Preferred: 1. Society of Clinical Research Associates Certification. 2. Certified Clinical Research Professional.

Options

Keywords: Meridian Health Services, Hackensack, Posting Title Protocol Submission Coordinator,Cancer Ctr Clinical Research, Healthcare, Hackensack, New Jersey

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