Clinical Trial Associate

Clinical --> Clinical Development

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

The Clinical Trial Associate is a key member of our clinical team and plays a valuable role in supporting and facilitating the efficient conduct of our clinical trials.

• Supports the clinical team and the Clinical Project Manager in the overall management of trials, including planning, execution and closeout of one or more clinical trials
• Assists the Associate Director, Clinical Monitoring with site management activities, including review of monitoring reports and tracking of site visits
• Communicates effectively with internal and external trial personnel (investigative staff, vendors, etc)
• Supports the clinical team with planning and preparation for meetings and conferences
• Assists the Clinical Project Manager with preparation of external and internal documentation for assigned trials and provides trial status updates as requested
• Supports scheduling meetings and documentation associated with the meetings for clinical operations (i.e. agendas, minutes)
• Supports creation and tracking of clinical trial deliverables, milestones and timelines including entry of information into relevant systems
• Participates in and provides support for vendor identification and management (e.g., CROs, IVRS, Central Labs, etc)
• Assists with the development of vendor and site budgets and supports invoice and budget activities
• Updates internal and external systems
• Assists with the maintenance of the Trial Master File
• Supports organization and management of document drafts and maintenance of electronic document management system
• Follow established SOPs and other applicable regulatory requirements across all tasks
• Participates in clinical operations initiatives and programs as assigned
• Identifies and communicates quality and compliance concerns
• Other duties and responsibilities as required.

Basic Qualifications

• B.S/B.A. degree
• Minimum of 2 years' professional experience
• Minimum 1 year of clinical research experience
• Prior experience in the biotech, pharmaceutical, or medical device industry is preferred

Preferred Qualifications

• Exceptional organization and attention to detail.
• Excellent interpersonal, oral and written communication and presentation skills.
• Excellent Microsoft Office skills
• Preferable
• Knowledge of ICH-GCP Guidelines and other regulatory requirements of clinical trial management

Compensation:

Targeted Base: 91,375 - 113,320*

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.