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Research Project Mgmt Coord 40 hrs/week

Job Summary:
Performs various administrative functions to assist with research activities across the Research Program. Creates and plans regulatory submissions, study budgeting, and contracting for research projects across the Research Program. Participates and functions as super-user for research initiatives that have cross-team impact.

Primary Duties
1. 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) (and subsequent amendment) requirements, special provisions, terms and conditions, and budget analysis to ensure compliance with appropriate laws, regulations, corporate policies and business unit procedures.
2. Facilitates study start up coordination between Clinical Research Coordinators, Study Manager, Team Leadership, CROs and study sponsors.
3. Provides support in all aspects of purchasing goods, services and ordering supplies, e.g., obtaining vendor quotes, statement of work preparation, purchase order submission and invoice resolution, and ensures compliance with vendors contractual expectations.
4. Functions as Project Lead on new Investigator Initiated Trials (IITs), new Principal Investigators (PIs), and new research initiatives at EHRP.
5. Acts as a forward-thinking LEAN facilitator for quality improvement initiatives and change leader for new processes at EHRP.
6. Manages activities across EHRP for new IITs and new departments/PIs engaging in research, including but not limited to, project management, proposal development/writing, identifying extramural funding for IIT grants, award management, and technical assistance.
7. Coordinates study start up activities for EvergreenHealth-sponsored multi-center IITs.
8. Coordinates protocol, informed consent form (ICF) and contract and manuscript development for IITs to include technical writing, editing, supplementing, proofreading, creating charts/graphs, and formatting IIT documents consistent with local and institutional standards.
9. Independently completes all study start up regulatory submissions, including consent form review and redlining, and submission to Institutional Review Boards (IRBs) and facilitates IRB-related inquiries across EvergreenHealth.
10. Coordinates submissions for IITs.
11. Provides administrative support to the Research Steering Committee (RSC) in the review of financial and logistical impact of all research studies at EHRP, including but not limited to working with PIs to complete relevant paperwork for meetings, taking meeting minutes, and sending notifications of approval.
12. Creates study project codes in appropriate EvergreenHealth financial and Oracle systems to facilitate tracking of each study across EvergreenHealth continuum.
13. Tracks and maintains updated records of all educational activities, training, licensure, and updated CVs for all of EHRP personnel.
14. Develops and maintains study master database with key project data, including start up and contracts metrics, to report out to Research Leadership
15. Provides support to the Research Leadership and coordinators in research activities as needed.
16. Coordinates and prepares the necessary documentation for Sponsor or FDA audits.
17. Markets recruiting studies to external audiences, via EHRP Online Website and CenterWatch updates, creates recruitment fliers for studies, recruitment submissions to local registries, and creates PowerPoint presentations for Patient Seminars.
18. Functions as key stakeholder and super-user for new process improvement initiatives undertaken by EHRP, including but not limited to Cerner and Clinical Trial Management Software (CTMS) projects.
19. Creates process maps, updates/writes standard operating procedures for EHRPA.
20. Performs other administrative duties as requested, including process Check Requests/Patient Stipends/Checks from Sponsors, manage the shared drive folders, electronic tools.
License, Certification, Education or Experience:

REQUIRED for the position:
* Bachelors 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, facility with oral and written communications
* 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.

DESIRED for the position:
* PMP certification
* 5 years of applicable experience (IRB, contract language review and editing, vendor administration)



Full time
Kirkland, WA 98033, US