Project Specialist II

Job Summary

INC Research employees don’t accept ordinary. From therapeutic experts to administrative support staff, each member of our 5,000-strong team continually searches for better. Whether that’s better clinical development through our unique Trusted Process®, or better insights from the 100-plus countries in which we operate. It means we deliver success faster, not only for our customers and the patients we serve, but also ourselves.

As such we are recruiting for a Project Specialist.
This role will be responsible for providing support in all administrative activities associated with the management of a clinical trial.
Actively participating in delivering results that meet Customer expectations, project goals, timelines, and assigned budget.
Providing overall study support to functional leads to ensure the successful completion of project deliverables.

Core Responsibilities

Project Administration - Attends Quick Start camp, Quality Finish Camp, and may attend process review and Kick-Off Meetings and other project meetings as required. Participates in Trial Master File audits. Assists in preparation for and attends investigator meetings. Prepares and maintains Study Reference Manual and site reference tools. Drafts and prepares documents for mass dissemination. Arranges for receipt of administrative and regulatory documents. Coordinates the packaging, shipping, and tracking of study supplies and materials. Transcribes accurate meeting minutes and action items to meet the specifications of the project team and Sponsor.
Reporting - Assists project team with compliance or maintenance of regulatory standards, Standard Operating Procedures (SOPs), and Work Instructions (WI). Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan. Reviews and submits Essential Regulatory Documents for second review. May conduct second review of Essential Regulatory Documents. Prepares and disseminates Investigator regulatory binder.

Communication - Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.

Training – May train new employees assigned to project.

Skills & Attributes

BA/BS in the science/health care field, nursing degree, or equivalent combination of education and experience.
Minimal clinical or research experience.
Database experience preferred.
Basic understanding of the drug development process.
Basic understanding of SOPs, WI, FDA, and local regulations, ICH guidelines, and Drug Development process.
Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail skills.
Strong organizational, presentation, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
Uses effective tools and strategies in written and verbal communication.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Why INC Research:
We provide competitive salaries, comprehensive benefits packages and the support and training available from working with a top ranking and award winning CRO. As one of the fastest-growing global providers of Phase I-IV services we offer experience spanning the globe, along with retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
INC Research offers endless opportunities to take your career in the direction you want – just follow your ambition.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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