Description

JOB SUMMARY

The Research Project Coordinator II is responsible for planning, developing, implementing, managing and reporting on multiple aspects of Neuro Oncology research program with in the Clinical Oncology Research Coordination Department. This position will use project management skills and tools to develop and implement strategies that ensure timely advancement of a proposed research program to meet intended goals and objectives while complying with all institutional, federal and state rules, regulations and funding constraints.

ESSENTIAL FUNCTIONS OF THE ROLE

Works with team leaders, management, and program investigators to define the strategic initiatives, scope, goals, and timelines of the Neuro Oncology research program.

Develops program budgets and ensures that budget requirements are met, including review of program-related contracts and approval of invoices within the program budget.

Prepares, facilitates and coordinates the process for accurate and timely submission of IRB applications for protocol revisions or amendments. Prepares and submits external serious adverse event reports per IRB reporting policy. Reads and interprets the information in MedWatch forms submitted by the sponsor for preparing SAE reports.

Prepares, maintains and updates regulatory binders for review by internal and external auditors and monitors. Prepares supporting documents, including the clinical protocol, investigator's brochure, case report forms, informed consent documents and components of an IND application.

Serves as a program liaison with internal and external departments and specifically, industry sponsors and partners, involved in or contributing to the program to resolve barriers to the advancement of the program's strategic initiatives. Uses project management skills to ensure that the program progresses according to established timelines.

Fosters relationships with external entities, including academia, pharmaceutical and biotechnology industries; maintains current relationships and establishes new relationships with entities that can contribute to the objectives of the program.

Designs and implements processes and procedures to ensure advancement of the program's strategic initiatives.

Provides guidance to program team members, and interacts regularly with the program team to determine resource needs, coordinate activities of operational areas and identify deliverables and target due dates.

Organizes and conducts team meetings to ensure adherence to strategic initiatives, goals, budget and timelines.

KEY SUCCESS FACTORS

Strong written and oral communication skills.

Proven leadership skills in project management, including project management tools and techniques.

Strong computer skills, including Microsoft office, Excel and PowerPoint.

Ability to manage time sensitive projects in order to meet deadlines.

Strong ability to establish and maintain effective working relationships.

Knowledge of the principles and practices of developing, administering and implementing a clinical trial in compliance with sponsor, federal, state and institutional regulations.

Able to work independently, coordinate multiple projects simultaneously and work efficiently to meet program timelines.

Ability to work in a matrix organization to effectively plan, organize and coordinate staff and resources, identify and resolve problems, and think critically and efficiently to advance program initiatives.

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 - 4 Years of Experience