Research Project Management Coordinator

EvergreenHealth • Kirkland, WA

96d • $34 - $54

About The Position

The position involves performing various administrative functions to assist with research activities across the Research Program. The role includes creating and planning regulatory submissions, study budgeting, and contracting for research projects. The individual will participate and function as a super-user for research initiatives that have cross-team impact.

Requirements

• Bachelor’s degree.
• 3 years of applicable work experience (IRB, contract language review and editing, vendor administration).
• Strong project management skills.
• Previous work in clinical trials program or industry with significant exposure to managing study contracts, IRB and regulatory paperwork.
• Knowledge of FDA regulations, ICH guidelines, GCPs, research terminology and clinical trial processes and contract terms.
• Highly organized, able to manage multiple priorities.
• Proficient technical skills with Research-required software including Microsoft Office (Excel, Word, PowerPoint, Visio), Adobe Acrobat, and Internet research skills.
• Ability to work in fast-paced environment.
• Strong independent contributor, proactive, presents leadership skills, demonstrates good judgment and problem solving skills.

Nice To Haves

• PMP certification.
• 5 years of applicable experience (IRB, contract language review and editing, vendor administration).

Responsibilities

• Independently analyzes and edits all Confidential Disclosure Agreement (CDA), Clinical Trial Agreement (CTA), and Business Services Agreement (BSA) and all other contractual/legal documents for the EvergreenHealth Research Program (EHRP).
• Facilitates study start up coordination between Clinical Research Coordinators, Study Manager, Team Leadership, CROs and study sponsors.
• Provides support in all aspects of purchasing goods, services and ordering supplies.
• Functions as Project Lead on new Investigator Initiated Trials (IITs), new Principal Investigators (PIs), and new research initiatives at EHRP.
• Acts as a forward-thinking LEAN facilitator for quality improvement initiatives and change leader for new processes at EHRP.
• Manages activities across EHRP for new IITs and new departments/PIs engaging in research.
• Coordinates study start up activities for EvergreenHealth-sponsored multi-center IITs.
• Coordinates protocol, informed consent form (ICF) and contract and manuscript development for IITs.
• Independently completes all study start up regulatory submissions.
• Coordinates clinicaltrials.gov submissions for IITs.
• Provides administrative support to the Research Steering Committee (RSC).
• Creates study project codes in appropriate EvergreenHealth financial and Oracle systems.
• Tracks and maintains updated records of all educational activities, training, licensure, and updated CVs for all of EHRP personnel.
• Develops and maintains study master database with key project data.
• Provides support to the Research Leadership and coordinators in research activities as needed.
• Coordinates and prepares the necessary documentation for Sponsor or FDA audits.
• Markets recruiting studies to external audiences.
• Functions as key stakeholder and super-user for new process improvement initiatives.
• Creates process maps, updates/writes standard operating procedures for EHRPA.
• Performs other administrative duties as requested.

Benefits

• Medical, vision and dental insurance.
• On-demand virtual health care.
• Health Savings Account.
• Flexible Spending Account.
• Life and disability insurance.
• Retirement plans 457(b) and 401(a) with employer contribution.
• Tuition assistance for undergraduate and graduate degrees.
• Federal Public Service Loan Forgiveness program.
• Paid Time Off/Vacation.
• Extended Illness Bank/Sick Leave.
• Paid holidays.
• Voluntary hospital indemnity insurance.
• Voluntary identity theft protection.
• Voluntary legal insurance.
• Pay in lieu of benefits premium program.
• Free parking.
• Commuter benefits.
• Cafeteria & Gift Shop Discount.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees