Job Title: Project Specialist I (FHI Clinical)

Job Location : United States of America

Time type : Full time

About The Company

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

Summary of the Position:

The Project Specialist performs administrative and supportive activities assigned by Clinical Operations leadership to ensure the contracted services and expectations are carried out by FHI Clinical in accordance with executed contracts and the customers’ expectations.

Essential Functions:

• Maintain Project Management dashboards via SharePoint, Smartsheets or Clinical Trial Management Systems and a variety of databases and system
• Creates and maintains tracking of data required for clinical operations services
• Provides support to senior management with key performance indicator updates
• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings)
• Follows up with FHIC project teams on action items to closure
• Coordinates global teleconferences including meeting invites and presentations in support of monthly teleconferences
• Maintains timely and effective communication among internal and external team members
• Keeps Clinical Operations Leadership and applicable project team members fully appraised of activities and updates
• Assist with new hire onboarding for Clinical Operations employees
• May contact site staff as needed for critical information
• Provide administrative support to Clinical Operations staff and functional leads
• Ensure all study documents are archived based on the appropriate guidelines and policy
• Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues
• Maintain professional relationships with team members, Company staff and study site staff
• Set and meet personal and professional goals and objectives
• All other duties as assigned

Knowledge, Skills and Abilities:

• Working level of understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• Strong verbal and written communication and negotiation skills
• Strong organizational skills
• Previous experience with database and clinical management system
• Ability to prioritize and manage multiple tasks with demonstrated ability to meet deadlines
• Possess an understanding of medical and clinical research terminology
• Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items
• Driven self-starter with the ability to begin tasks independently and complete tasks without supervision
• Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment
• Demonstrated effective organizational skills and strong attention to detail
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Customer-service focused in approach to work, both internally and externally

Position Requirements:

Education:

• Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.

Required Job-related Experience:

• 1-2 years of related experience in the submission of clinical trial applications, regulatory affairs, clinical research, or clinical operations environment
• Knowledge of Good Clinical Practice, ICH guidelines and local regulatory authority drug research and development regulations preferred
• Expertise in ICH/GCP requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials
• Knowledge of site and institution specific contract requirements
• Proficiency in Microsoft Office suite and spreadsheets required. Proficiency in Smartsheet application preferred
• Able to professionally communicate in a clear, positive fashion with clients and staff
• Ability to work independently without direction
• Ability to adapt to a fast-paced environment requiring flexibility and task prioritization
• Must be able to read, write and speak fluent English.

Additional Eligibility Qualifications:

• Experience with electronic Trial Master File (eTMF), Clinical Trial Management Systems (CTMS) and SharePoint

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.

Travel Requirements:

• Expected travel time is up to 5% for this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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