PRAHS Sr Site Management Associate in United States
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
What will you be doing?
As a Site Management Associate, you are a primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site communication, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. You will work collaboratively with your study teams, sites, and clients. The Site Management Associate performs, essential document collection and review, clinical status tracking, in-house site management, and data review activities in accordance with the project protocol, client and/or PRA standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific)
- Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
Collects essential regulatory documents from sites, and ensuring compliance with regulatory and ICH/GCP guidelines and PRA SOPs.
Works with Informed Consent Form updates, collaborating with sites on updates and ensuring appropriate IRB submissions and approvals.
Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.
Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
Manages additional clinical operations tasks as required and outlined in study job task list.
What do you need to have?
Bachelor’s Degree Required, preferably in Science or Health Related Field; or, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
Experience using computerized information systems and standard application software (Windows, MS Office)
Excellent organizational and time management skills, with strong attention to detail
Exemplary communication, teamwork, and interpersonal skills
Superb resourcefulness, critical thinking, and problem solving skills with a solutions focus
Adaptability and ability to shift priorities as business needs change
Ability to quickly learn software and data systems that support clinical trial management
Read, write and speak English
1+ years of professional work experience in an office or medical/ dental setting preferred (Level 1)
Clinical trials support, data coordination, pharmaceutical industry, medical/ dental assistant, scientific study or research setting preferred
Office-based or clinical experience a plus
Experience with electronic data capture, PC Windows, word processing, and electronic spreadsheets a plus
Knowledge of ICH and local regulatory authority drug research and development regulations a plus
Prior customer service experience preferred
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/